(266 days)
The Halyard STERLING* Nitrile Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid are disposable devices intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
The following chemotherapy drugs and concentration had NO breakthrough detected up to 240 minutes: Azacitidine (Vidaza) (25 mg/mL) Bendamustine HCl (5 mg/mL) Bleomycin Sulfate (Blenoxane) (15 mg/mL) Bortezomib (Velcade) (1 mg/mL) Busulfan (6 mg/mL) Capecitabine (26 mg/mL) Carboplatin ( 10 mg/mL) Carfilzomib (2 mg/mL) Cetuximab (Erbitux) (2 mg/mL) Cisplatin (1 mg/mL) Cladribine (1 mg/mL) Cyclophosphamide (20 mg/mL) Cytarabine HCl (Cytosine) (100 mg/mL) Dacarbazine (DTIC) (10 mg/mL) Dactinomycin (0.5 mg/mL) Daunorubicin HCl (5 mg/mL) Decitabine ( 5 mg/mL) Docetaxel HCl (20 mg/mL) Doxorubicin HCl (2 mg/mL) Epirubicin HCl (Ellence) (2 mg/mL) Etoposide (20 mg/mL) Floxuridine (1 00mg/mL) 5-Fluorouracil (50 mg/mL) Gemcitabine HCl (38 mg/mL) Idarubicin HCl (1 mg/mL) lfosfamide (IFEX) (50 mg/mL) Irinotecan HCl (20 mg/mL) Lenvatinib (20mg/mL) Leuprolide Acetate Salt (5 mg/mL) Mechlorethamine HCl (1 mg/mL) Melphalan HCl (5 mg/mL) Methotrexate (25 mg/mL) Mitomycin C (0.5 mg/mL) Mitoxantrone HCl (2 mg/mL) Nelarabine (5 mg/mL) Oxaliplatin (5 mg/mL) Paclitaxel (Taxol) (6 mg/mL (6,000 ppm) Pemetrexed (25 mg/mL) Raltitrexed (0.5 mg/mL) Sorafenib Tosylate (200 mg/mL) Streptozocin (100mg/mL) Tamoxifen (2 mg/mL) Teniposide (10 mg/mL) Topotecan HCl (1 mg/mL) Trisenox (Arsenic Trioxide) (1 mg/mL) Vinblastine Sulfate (1 mg/mL) Vincristine Sulfate (Oncovin) (1 mg/mL) Vinorelbine (10 mg/mL)
The following chemotherapy drugs and concentration showed breakthrough detected in less than 30 minutes: Carmustine (3.3 mg/mL), breakthrough detected at 22.9 minutes
The following chemotherapy drugs and concentration showed breakthrough detected in less than 40 minutes: ThioTEPA (10 mg/mL), breakthrough detected at 37.1 minutes
Warning: Do not use with Carmustine or ThioTEPA
The following hazardous drugs (opioids) and concentration had NO breakthrough detected up to 240 minutes: Fentanyl Citrate Injection (100 mcg/2 mL) Simulated Gastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 Solution
The Halyard STERLING SG* SENSI-GUARD Powder-Free Nitrile Exam Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid are disposable devices intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
The following chemotherapy drugs and concentration had NO breakthrough detected up to 240 minutes: Azacitidine (Vidaza) (25 mg/mL) Bendamustine HCl (5 mg/mL) Bleomycin Sulfate (Blenoxane) (15 mg/mL) Bortezomib (Velcade) (1 mg/mL) Busulfan (6 mg/mL) Capecitabine (26 mg/mL) Carboplatin ( 10 mg/mL) Carfilzomib (2 mg/mL) Cetuximab (Erbitux) (2 mg/mL) Cisplatin (1 mg/mL) Cladribine (1 mg/mL) Cyclophosphamide (20 mg/mL) Cytarabine HCl (Cytosine) (100 mg/mL) Dacarbazine (DTIC) (10 mg/mL) Dactinomycin (0.5 mg/mL) Daunorubicin HCl (5 mg/mL) Decitabine ( 5 mg/mL) Docetaxel HCl (20 mg/mL) Doxorubicin HCl (2 mg/mL) Epirubicin HCl (Ellence) (2 mg/mL) Etoposide (20 mg/mL) Eribulin Mesylate (0.5 mg/mL) Fludarabine (25 mg/mL) 5-Fluorouracil (50 mg/mL) Gemcitabine HCl (38 mg/mL) Idarubicin HCl (1 mg/mL) lfosfamide (IFEX) (50 mg/mL) Irinotecan HCl (20 mg/mL) Lenvatinib (20 mg/mL) Leuprolide Acetate Salt (5 mg/mL) Mechlorethamine HCl (1 mg/mL) Melphalan HCl (5 mg/mL) Methotrexate (25 mg/mL) Mitomycin C (0.5 mg/mL) Mitoxantrone HCl (2 mg/mL) Oxaliplatin (5 mg/mL) Paclitaxel (Taxol) (6 mg/mL (6,000 ppm) Pemetrexed (25 mg/mL) Raltitrexed (0.5 mg/mL) Ritux1mab ( 10 mg/mL) Sorafenib Tosylate (200 mg/mL) Tamoxifen (2 mg/mL) Topotecan HCl (1 mg/mL) Trisenox (Arsenic Trioxide) (1 mg/mL) Vinblastine Sulfate (1 mg/mL) Vincristine Sulfate (Oncovin) (1 mg/mL) Vinorelbine (10 mg/mL)
The following chemotherapy drugs and concentration showed breakthrough detected in less than 20 minutes: Carmustine (BCNU) (3.3 mg/ml), breakthrough detected at 14.8 minutes
The following chemotherapy drugs and concentration showed breakthrough detected in less than 30 minutes: ThioTEPA (10 mg/ml), breakthrough detected at 23.9 minutes
Warning: Do not use with Carmustine or ThioTEPA
The following hazardous drugs (opioids) and concentration had NO breakthrough detected up to 240 minutes: Fentanyl Citrate Injection (100 mcg/2 mL) Simulated Gastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 Solution
The following hazardous drugs and concentration had NO breakthrough detected up to 240 minutes: Cyclosporin A (100 mg/mL) Cytovene (Ganciclovir) (10 mg/mL) Retrovir (Zidovudine) (10 mg/mL)
The Halyard STERLING NITRILE-XTRA* Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs. Fentanyl Citrate and Gastric Acid are disposable devices intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
The following chemotherapy drugs and concentration had NO breakthrough detected up to 240 minutes: Azacitidine (Vidaza) (25 mg/mL) Bendamustine HCl (5 mg/mL) Bleomycin Sulfate (Blenoxane) (15 mg/mL) Bortezomib (Velcade) (1 mg/mL) Busulfan (6 mg/mL) Capecitabine (26 mg/mL) Carboplatin ( 10 mg/mL) Carfilzomib (2 mg/mL) Cetuximab (Erbitux) (2 mg/mL) Cisplatin (1 mg/mL) Cladribine (1 mg/mL) Cyclophosphamide (20 mg/mL) Cytarabine HCl (Cytosine) (100 mg/mL) Dacarbazine (DTIC) (10 mg/mL) Dactinomycin (0.5 mg/mL) Daunorubicin HCl (5 mg/mL) Decitabine ( 5 mg/mL) Docetaxel HCl (20 mg/mL) Doxorubicin HCl (2 mg/mL) Epirubicin HCl (Ellence) (2 mg/mL) Etoposide (20 mg/mL) Floxuridine (100 mg/mL) Fludarabine (25 mg/mL) 5-Fluorouracil (50 mg/mL) Gemcitabine HCl (38 mg/mL) Idarubicin HCl (1 mg/mL) lfosfamide (IFEX) (50 mg/mL) Irinotecan HCl (20 mg/mL) Lenvatinib (20 mg/mL) Leuprolide Acetate Salt (5 mg/mL) Mechlorethamine HCl (1 mg/mL) Melphalan HCl (5 mg/mL) Methotrexate (25 mg/mL) Mitomycin C (0.5 mg/mL) Mitoxantrone HCl (2 mg/mL) Nelarabine (5 mg/mL) Oxaliplatin (5 mg/mL) Paclitaxel (Taxol) (6 mg/mL (6,000 ppm) Pemetrexed (25 mg/mL) Ralt1trexed (0.5 mg/mL) Rituximab ( 10 mg/mL) Sorafenib Tosylate (200 mg/mL) Streptozocin (100 mg/mL) Tamoxifen (2 mg/mL) Teniposide (10 mg/mL) Topotecan HCl (1 mg/mL) Trisenox (Arsenic Trioxide) (1 mg/mL) Vinblastine Sulfate (1 mg/mL) Vincristine Sulfate (Oncovin) (1 mg/mL) Vinorelbine (10 mg/mL)
The following chemotherapy drugs and concentration showed breakthrough detected in less than 30 minutes: Carmustine (3.3 mg/ml), breakthrough detected at 25.2 minutes
The following chemotherapy drugs and concentration showed breakthrough detected in less than 40 minutes: ThioTEPA (10 mg/ml), breakthrough detected at 35.5 minutes
Warning: Do not use with Carmustine or ThioTEPA
The following hazardous drugs (opioids) and concentration had NO breakthrough detected up to 240 minutes: Fentanyl Citrate Injection (100 mcg/2 mL) Simulated Gastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 Solution
The subject devices are disposable, grey-colored, chlorinated, nitrile, powder-free, textured fingertip, ambidextrous, non-sterile patient examination gloves that are packed in a cardboard dispenser box.
The provided document is a 510(k) Premarket Notification from the U.S. FDA for Halyard STERLING Nitrile Powder-Free Exam Gloves and related products. It outlines the regulatory classification, intended use, and a comparison of technological characteristics and performance data against predicate and reference devices to demonstrate substantial equivalence.
Based on the content, this document describes physical and chemical testing of medical gloves, not an AI/ML-enabled medical device. Therefore, many of the requested
details, such as sample size for test/training sets, data provenance, expert
ground truth establishment, adjudication methods, MRMC studies, standalone
algorithm performance, and specific effect sizes for human readers with/without
AI assistance, are not applicable to this document.
However, I can extract the acceptance criteria and reported device performance for these physical products based on the provided tables.
Acceptance Criteria and Reported Device Performance
The acceptance criteria for these medical gloves are based on various ASTM and ISO standards for physical properties, residual powder, and biological safety. The "Reported device performance" directly aligns with the "Subject Devices" column in the "PERFORMANCE CHARACTERISTICS OF THE SUBJECT DEVICE" table.
Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard & Requirement) | Reported Device Performance (Subject Devices) |
|---|---|
| ASTM D5151-06 Standard Test Method for Detection of Holes in Medical Gloves: • Meets 2.5% AQL (Acceptable Quality Level) requirement for leakage. | Halyard STERLING Nitrile Powder-Free Exam Gloves, Halyard STERLING SG SENSI-GUARD Powder-Free Nitrile Exam Gloves, Halyard STERLING NITRILE-XTRA Powder-Free Exam Gloves: • Meets the 2.5% AQL requirement for leakage. |
| ASTM D6124-06 Standard Test Method for Residual Powder on Medical Gloves: • Residual powder < 2 mg maximum per glove (powder-free limit). | • Residual powder is within the powder-free limit of < 2 mg maximum powder per glove. |
| ASTM D6319-10 Standard Specification for Nitrile Examination Gloves for Medical Applications: • Physical dimensions within standard limits. • Physical properties (tensile strength) meet requirements before and after aging. | • Physical dimensions are within the limits of the standard. • Physical properties met the requirements for tensile strength before and after aging. |
| ISO 10993-11: 2017 Biological evaluation of medical devices – Tests for systemic toxicity: • No acute systemic toxicity. | • Did not elicit acute systemic toxicity. |
| ISO 10993-23: 2021 Biological Evaluation of Medical Devices - Part 23: Tests for Irritation: • Considered non-irritating. | • Considered non-irritating. |
| ISO 10993-10: 2010 Biological evaluation of medical devices – Tests for skin sensitization: • Considered non-sensitizing. | • Considered non-sensitizing. |
| Clinical Test (Jordan-King modification of the Draize test for Type IV allergic contact sensitization): • Non-irritating and no clinical evidence of residual chemical additives that may induce Type IV allergy. | • Was non-irritating and showed no clinical evidence of residual chemical additives that may induce Type IV allergy in human subjects. |
| Chemotherapy Drug Permeation (ASTM D6978-05): • No breakthrough detected up to 240 minutes for listed drugs. • Breakthrough detected at specified times for Carmustine and ThioTEPA. | • Halyard STERLING NPF: All listed drugs (39) had no breakthrough up to 240 minutes, except Carmustine (22.9 min) and ThioTEPA (37.1 min). • Halyard STERLING SG NPF: All listed drugs (43) had no breakthrough up to 240 minutes, except Carmustine (14.8 min) and ThioTEPA (23.9 min). • Halyard STERLING NITRILE-XTRA NPF: All listed drugs (44) had no breakthrough up to 240 minutes, except Carmustine (25.2 min) and ThioTEPA (35.5 min). |
| Fentanyl Citrate / Gastric Acid Permeation: • No breakthrough detected up to 240 minutes for Fentanyl Citrate (100 mcg/2 mL) and Simulated Gastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 Solution. | • No breakthrough detected up to 240 minutes for Fentanyl Citrate (100 mcg/2 mL) and Simulated Gastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 Solution for all three glove types. |
| Additional Hazardous Drugs (for Halyard STERLING SG NPF only): • No breakthrough detected up to 240 minutes for Cyclosporin A (100 mg/mL), Cytovene (Ganciclovir) (10 mg/mL), Retrovir (Zidovudine) (10 mg/mL). | • No breakthrough detected up to 240 minutes for Cyclosporin A (100 mg/mL), Cytovene (Ganciclovir) (10 mg/mL), Retrovir (Zidovudine) (10 mg/mL). |
Study Details (Relevant to this document type)
This 510(k) submission primarily relies on non-clinical (bench) testing and one clinical test for biological evaluation, generally comparing the subject devices to legally marketed predicate devices to demonstrate substantial equivalence.
-
Sample size used for the test set and the data provenance:
- Clinical Test (Biological Evaluation - Low Dermatitis Potential): A 204-subject study was completed. The provenance of this data (e.g., country of origin, retrospective or prospective) is not explicitly stated in the provided text, but clinical studies for FDA submissions are typically prospective.
- Non-Clinical Tests (ASTM & ISO standards): The sample sizes for the various physical and chemical tests (e.g., hole detection, residual powder, tensile strength, chemical permeation) are determined by the specific ASTM and ISO standards referenced (e.g., ASTM D5151-06 specifies AQL for hole detection, which implies a sampling plan). The document does not specify the exact number of gloves or test replicates used for each test, only that the "subject device meets" the criteria of the standards. Data provenance is not specified beyond being generated from the manufacturer's testing.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. For physical device performance, "ground truth" is established by the specified test methodologies (e.g., ASTM D5151 for holes, ASTM D6978 for permeation) and controlled laboratory conditions, not human expert interpretation of images or patient data. The clinical test involved "normal healthy human volunteers" but did not require expert consensus for "ground truth" in the way an AI diagnostic study would.
-
Adjudication method: Not applicable. As this is not an AI/ML-driven diagnostic study, there's no need for adjudication of human reader interpretations.
-
If a multi reader multi case (MRMC) comparative effectiveness study was done: No, this type of study is not applicable to medical gloves.
-
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. No algorithm is involved.
-
The type of ground truth used:
- For the performance characteristics related to physical properties, residual powder, and chemical permeation: Defined by standardized test methods (ASTM D5151, D6124, D6319, D6978). These are objective, quantitative measurements.
- For biological evaluation (systemic toxicity, irritation, sensitization): Defined by standardized biological tests (ISO 10993-11, 10993-23, 10993-10) and a specific clinical study (Jordan-King modification of the Draize test). The "ground truth" here is the biological response observed according to the protocols.
-
The sample size for the training set: Not applicable. These are physical devices, so there is no "training set" in the context of an AI/ML model.
-
How the ground truth for the training set was established: Not applicable. No training set for an AI/ML model.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 22, 2024
O&M Halyard, Inc. Caitlin Senter Director. Global Regulatory Affairs 1 Edison Drive Alpharetta, Georgia 30005
Re: K231938
Trade/Device Name: Halyard STERLING* Nitrile Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid; Halyard STERLING SG* SENSI-GUARD Powder-Free Nitrile Exam Gloves, Low Dermatitis Potential. Tested for use with Chemotherapy Drugs. Fentanyl Citrate and Gastric Acid; Halyard STERLING NITRILE-XTRA * Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I. reserved Product Code: LZA, LZC, OPJ, QDO Dated: February 23, 2024 Received: February 23, 2024
Dear Caitlin Senter:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of
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Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
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Sincerely,
Allan Guan -S
For Bifeng Qian, M.D., Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic and Reconstructive Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K231938
Device Name
Halyard STERLING* Nitrile Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid
Indications for Use (Describe)
The Halyard STERLING* Nitrile Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs. Fentanyl Citrate and Gastric Acid are disposable devices intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
The following chemotherapy drugs and concentration had NO breakthrough detected up to 240 minutes: Azacitidine (Vidaza) (25 mg/mL) Bendamustine HCl (5 mg/mL) Bleomycin Sulfate (Blenoxane) (15 mg/mL) Bortezomib (Velcade) (1 mg/mL) Busulfan (6 mg/mL) Capecitabine (26 mg/mL) Carboplatin ( 10 mg/mL) Carfilzomib (2 mg/mL) Cetuximab (Erbitux) (2 mg/mL) Cisplatin (1 mg/mL) Cladribine (1 mg/mL) Cyclophosphamide (20 mg/mL) Cytarabine HCl (Cytosine) (100 mg/mL) Dacarbazine (DTIC) (10 mg/mL) Dactinomycin (0.5 mg/mL) Daunorubicin HCl (5 mg/mL) Decitabine ( 5 mg/mL) Docetaxel HCl (20 mg/mL) Doxorubicin HCl (2 mg/mL) Epirubicin HCl (Ellence) (2 mg/mL) Etoposide (20 mg/mL) Floxuridine (1 00mg/mL) 5-Fluorouracil (50 mg/mL) Gemcitabine HCl (38 mg/mL) Idarubicin HCl (1 mg/mL) lfosfamide (IFEX) (50 mg/mL) Irinotecan HCl (20 mg/mL) Lenvatinib (20mg/mL) Leuprolide Acetate Salt (5 mg/mL) Mechlorethamine HCl (1 mg/mL) Melphalan HCl (5 mg/mL) Methotrexate (25 mg/mL) Mitomycin C (0.5 mg/mL) Mitoxantrone HCl (2 mg/mL) Nelarabine (5 mg/mL) Oxaliplatin (5 mg/mL) Paclitaxel (Taxol) (6 mg/mL (6,000 ppm) Pemetrexed (25 mg/mL) FORM FDA 3881 (8/23) Page 1 of 2
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Raltitrexed (0.5 mg/mL) Sorafenib Tosylate (200 mg/mL) Streptozocin (100mg/mL) Tamoxifen (2 mg/mL) Teniposide (10 mg/mL) Topotecan HCl (1 mg/mL) Trisenox (Arsenic Trioxide) (1 mg/mL) Vinblastine Sulfate (1 mg/mL) Vincristine Sulfate (Oncovin) (1 mg/mL) Vinorelbine (10 mg/mL)
The following chemotherapy drugs and concentration showed breakthrough detected in less than 30 minutes: Carmustine (3.3 mg/mL), breakthrough detected at 22.9 minutes
The following chemotherapy drugs and concentration showed breakthrough detected in less than 40 minutes: ThioTEPA (10 mg/mL), breakthrough detected at 37.1 minutes
Warning: Do not use with Carmustine or ThioTEPA
The following hazardous drugs (opioids) and concentration had NO breakthrough detected up to 240 minutes: Fentanyl Citrate Injection (100 mcg/2 mL) Simulated Gastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 Solution
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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Indications for Use
510(k) Number (if known) K231938
Device Name
Halyard STERLING SG* SENSI-GUARD Powder-Free Nitrile Exam Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid
Indications for Use (Describe)
The Halyard STERLING SG* SENSI-GUARD Powder-Free Nitrile Exam Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid are disposable devices intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
The following chemotherapy drugs and concentration had NO breakthrough detected up to 240 minutes: Azacitidine (Vidaza) (25 mg/mL) Bendamustine HCl (5 mg/mL) Bleomycin Sulfate (Blenoxane) (15 mg/mL) Bortezomib (Velcade) (1 mg/mL) Busulfan (6 mg/mL) Capecitabine (26 mg/mL) Carboplatin ( 10 mg/mL) Carfilzomib (2 mg/mL) Cetuximab (Erbitux) (2 mg/mL) Cisplatin (1 mg/mL) Cladribine (1 mg/mL) Cyclophosphamide (20 mg/mL) Cytarabine HCl (Cytosine) (100 mg/mL) Dacarbazine (DTIC) (10 mg/mL) Dactinomycin (0.5 mg/mL) Daunorubicin HCl (5 mg/mL) Decitabine ( 5 mg/mL) Docetaxel HCl (20 mg/mL) Doxorubicin HCl (2 mg/mL) Epirubicin HCl (Ellence) (2 mg/mL) Etoposide (20 mg/mL) Eribulin Mesylate (0.5 mg/mL) Fludarabine (25 mg/mL) 5-Fluorouracil (50 mg/mL) Gemcitabine HCl (38 mg/mL) Idarubicin HCl (1 mg/mL) lfosfamide (IFEX) (50 mg/mL) Irinotecan HCl (20 mg/mL) Lenvatinib (20 mg/mL) Leuprolide Acetate Salt (5 mg/mL) Mechlorethamine HCl (1 mg/mL) Melphalan HCl (5 mg/mL) Methotrexate (25 mg/mL) Mitomycin C (0.5 mg/mL) Mitoxantrone HCl (2 mg/mL) Oxaliplatin (5 mg/mL) Paclitaxel (Taxol) (6 mg/mL (6,000 ppm) Pemetrexed (25 mg/mL)
FORM FDA 3881 (8/23)
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Raltitrexed (0.5 mg/mL) Ritux1mab ( 10 mg/mL) Sorafenib Tosylate (200 mg/mL) Tamoxifen (2 mg/mL) Topotecan HCl (1 mg/mL) Trisenox (Arsenic Trioxide) (1 mg/mL) Vinblastine Sulfate (1 mg/mL) Vincristine Sulfate (Oncovin) (1 mg/mL) Vinorelbine (10 mg/mL)
The following chemotherapy drugs and concentration showed breakthrough detected in less than 20 minutes: Carmustine (BCNU) (3.3 mg/ml), breakthrough detected at 14.8 minutes
The following chemotherapy drugs and concentration showed breakthrough detected in less than 30 minutes: ThioTEPA (10 mg/ml), breakthrough detected at 23.9 minutes
Warning: Do not use with Carmustine or ThioTEPA
The following hazardous drugs (opioids) and concentration had NO breakthrough detected up to 240 minutes: Fentanyl Citrate Injection (100 mcg/2 mL) Simulated Gastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 Solution
The following hazardous drugs and concentration had NO breakthrough detected up to 240 minutes: Cyclosporin A (100 mg/mL) Cytovene (Ganciclovir) (10 mg/mL) Retrovir (Zidovudine) (10 mg/mL)
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response. including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
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{7}------------------------------------------------
Indications for Use
510(k) Number (if known) K231938
Device Name
Halyard STERLING NITRILE-XTRA* Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid
Indications for Use (Describe)
The Halyard STERLING NITRILE-XTRA* Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs. Fentanyl Citrate and Gastric Acid are disposable devices intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
The following chemotherapy drugs and concentration had NO breakthrough detected up to 240 minutes: Azacitidine (Vidaza) (25 mg/mL) Bendamustine HCl (5 mg/mL) Bleomycin Sulfate (Blenoxane) (15 mg/mL) Bortezomib (Velcade) (1 mg/mL) Busulfan (6 mg/mL) Capecitabine (26 mg/mL) Carboplatin ( 10 mg/mL) Carfilzomib (2 mg/mL) Cetuximab (Erbitux) (2 mg/mL) Cisplatin (1 mg/mL) Cladribine (1 mg/mL) Cyclophosphamide (20 mg/mL) Cytarabine HCl (Cytosine) (100 mg/mL) Dacarbazine (DTIC) (10 mg/mL) Dactinomycin (0.5 mg/mL) Daunorubicin HCl (5 mg/mL) Decitabine ( 5 mg/mL) Docetaxel HCl (20 mg/mL) Doxorubicin HCl (2 mg/mL) Epirubicin HCl (Ellence) (2 mg/mL) Etoposide (20 mg/mL) Floxuridine (100 mg/mL) Fludarabine (25 mg/mL) 5-Fluorouracil (50 mg/mL) Gemcitabine HCl (38 mg/mL) Idarubicin HCl (1 mg/mL) lfosfamide (IFEX) (50 mg/mL) Irinotecan HCl (20 mg/mL) Lenvatinib (20 mg/mL) Leuprolide Acetate Salt (5 mg/mL) Mechlorethamine HCl (1 mg/mL) Melphalan HCl (5 mg/mL) Methotrexate (25 mg/mL) Mitomycin C (0.5 mg/mL) Mitoxantrone HCl (2 mg/mL) Nelarabine (5 mg/mL) Oxaliplatin (5 mg/mL) Paclitaxel (Taxol) (6 mg/mL (6,000 ppm)
{8}------------------------------------------------
Pemetrexed (25 mg/mL) Ralt1trexed (0.5 mg/mL) Rituximab ( 10 mg/mL) Sorafenib Tosylate (200 mg/mL) Streptozocin (100 mg/mL) Tamoxifen (2 mg/mL) Teniposide (10 mg/mL) Topotecan HCl (1 mg/mL) Trisenox (Arsenic Trioxide) (1 mg/mL) Vinblastine Sulfate (1 mg/mL) Vincristine Sulfate (Oncovin) (1 mg/mL) Vinorelbine (10 mg/mL)
The following chemotherapy drugs and concentration showed breakthrough detected in less than 30 minutes: Carmustine (3.3 mg/ml), breakthrough detected at 25.2 minutes
The following chemotherapy drugs and concentration showed breakthrough detected in less than 40 minutes: ThioTEPA (10 mg/ml), breakthrough detected at 35.5 minutes
Warning: Do not use with Carmustine or ThioTEPA
The following hazardous drugs (opioids) and concentration had NO breakthrough detected up to 240 minutes: Fentanyl Citrate Injection (100 mcg/2 mL) Simulated Gastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 Solution
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{9}------------------------------------------------
Image /page/9/Picture/0 description: The image shows the logo for Owens & Minor. The logo consists of a stylized "OM" in a dark red color, with the "O" being a circle with horizontal lines running through it. To the right of the "OM" is the text "Owens & Minor" in a gray color. The text is in a serif font and is slightly smaller than the "OM" symbol.
510(k)Summary - K231938
| Date Summarywas Prepared | March 22, 2024 |
|---|---|
| 510(k) Submitter | O & M Halyard, Inc.1 Edison DriveAlpharetta, GA 30005 |
| Primary Contact forthis 510(k) Submission | Caitlin Senter, MS, RACTel: 678-221-7330Email: caitlin.senter@hyh.com |
| Marketed Common Name | Nitrile Powder-Free Exam Gloves |
| Device Submission Trade nameand Description | Halyard STERLING* Nitrile Powder-Free Exam Gloves, Low DermatitisPotential, Tested for use with Chemotherapy Drugs, Fentanyl Citrate andGastric Acid,Halyard STERLING SG* SENSI-GUARD Powder-Free Nitrile Exam Gloves, LowDermatitis Potential, Tested for use with Chemotherapy Drugs, FentanylCitrate and Gastric AcidHalyard STERLING NITRILE-XTRA * Powder-Free Exam Gloves, Low DermatitisPotential, Tested for use with Chemotherapy Drugs, Fentanyl Citrate andGastric Acid |
| Device Common Name | Medical Exam Gloves |
| Device Product Codeand Classification Name | LZA Class I, 21 CFR §880.6250 Patient Examination GloveLZC Class I, 21 CFR §880.6250 Patient Examination Glove, Specialty;OPJ Class I, 21 CFR §880.6250 Medical Gloves With Chemotherapy LabelingClaims - Test For Use With Chemotherapy DrugsQDO Class I, 21 CFR §880.6250 Fentanyl and other opioid protection glove |
| Predicate Device | Halyard Sterling* Nitrile Powder-Free Exam Gloves, Halyard Sterling SG*Nitrile Sensi-Guard Powder-Free Exam Gloves (K191230) |
| Reference Device | Halyard Purple Xtra and Purple Sterile, Low Dermatitis Potential, Powder-FreeExam Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate(K192241) |
| Subject Device Description | The subject devices are disposable, grey-colored, chlorinated, nitrile,powder-free, textured fingertip, ambidextrous, non-sterile patientexamination gloves that are packed in a cardboard dispenser box. |
| The devices follow consensus standards: | |
| ASTM D5151-06 Standard Test Method for Detection of Holes in MedicalGloves | |
| ASTM D6319-10 Standard Specification for Nitrile Examination Gloves forMedical Applications | |
| ASTM D6124-06 Standard Test Method for Residual Powder on MedicalGloves | |
| ASTM D6978-05 Standard Practice for Assessment of Resistance of MedicalGloves to Permeation by Chemotherapy Drugs | |
| ISO 10993-11: 2017 Biological evaluation of medical devices – Tests forsystemic toxicity. | |
| ISO 10993-23: 2021 Biological Evaluation of Medical Devices - Part 23: Testsfor Irritation | |
| ISO 10993-10: 2010 Biological evaluation of medical devices – Tests for skinsensitization | |
| Indications for Use for HalyardSTERLING* Nitrile Powder-FreeExam Gloves, Low DermatitisPotential, Tested for use withChemotherapy Drugs, FentanylCitrate and Gastric Acid | The Halyard STERLING* Nitrile Powder-Free Exam Gloves, Low DermatitisPotential, Tested for use with Chemotherapy Drugs, Fentanyl Citrate andGastric Acid are disposable devices intended for medical purposes that isworn on the examiner's hand to prevent contamination between patient andexaminer.The following chemotherapy drugs and concentration had NO breakthroughdetected up to 240 minutes:Azacitidine (Vidaza) (25 mg/mL)Bendamustine HCl (5 mg/mL)Bleomycin Sulfate (Blenoxane) (15 mg/mL)Bortezomib (Velcade) (1 mg/mL)Busulfan (6 mg/mL)Capecitabine (26 mg/mL)Carboplatin ( 10 mg/mL)Carfilzomib (2 mg/mL)Cetuximab (Erbitux) (2 mg/mL)Cisplatin (1 mg/mL)Cladribine (1 mg/mL)Cyclophosphamide (20 mg/mL)Cytarabine HCl (Cytosine) (100 mg/mL)Dacarbazine (DTIC) (10 mg/mL)Dactinomycin (0.5 mg/mL)Daunorubicin HCl (5 mg/mL)Decitabine ( 5 mg/mL)Docetaxel HCl (20 mg/mL)Doxorubicin HCl (2 mg/mL)Epirubicin HCl (Ellence) (2 mg/mL)Etoposide (20 mg/mL)Floxuridine (100mg/mL)5-Fluorouracil (50 mg/mL)Gemcitabine HCl (38 mg/mL)Idarubicin HCl (1 mg/mL)Ifosfamide (IFEX) (50 mg/mL)Irinotecan HCl (20 mg/mL)Lenvatinib (20mg/mL)Leuprolide Acetate Salt (5 mg/mL)Mechlorethamine HCl (1 mg/mL)Melphalan HCl (5 mg/mL)Methotrexate (25 mg/mL)Mitomycin C (0.5 mg/mL)Mitoxantrone HCl (2 mg/mL)Nelarabine (5 mg/mL)Oxaliplatin (5 mg/mL)Paclitaxel (Taxol) (6 mg/mL (6,000 ppm)Pemetrexed (25 mg/mL)Raltitrexed (0.5 mg/mL)Sorafenib Tosylate (200 mg/mL)Streptozocin (100mg/mL)Tamoxifen (2 mg/mL)Teniposide (10 mg/mL) |
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Image /page/10/Picture/0 description: The image shows the logo for Owens & Minor. The logo consists of two parts: a stylized, maroon-colored emblem on the left and the company name "Owens & Minor" in gray on the right. The emblem is made up of the letters "OM" with horizontal lines running through them. The text is in a serif font and is stacked vertically.
{11}------------------------------------------------
Image /page/11/Picture/0 description: The image shows the logo for Owens & Minor. The logo consists of the letters "OM" in a dark red color, with horizontal lines running through the letters. To the right of the letters, the words "Owens & Minor" are written in a light gray color. The logo is simple and professional, and it is likely used to represent the company in its marketing and branding materials.
{12}------------------------------------------------
Image /page/12/Picture/0 description: The image shows the logo for Owens & Minor. The logo consists of a stylized "OM" in maroon color on the left, with horizontal lines running through the letters. To the right of the letters is the company name "Owens & Minor" in gray color. The font is serif and the ampersand is stylized.
| Topotecan HCl (1 mg/mL) |
|---|
| Trisenox (Arsenic Trioxide) (1 mg/mL) |
| Vinblastine Sulfate (1 mg/mL) |
| Vincristine Sulfate (Oncovin) (1 mg/mL) |
| Vinorelbine (10 mg/mL) |
The following chemotherapy drugs and concentration showed breakthrough detected in less than 30 minutes:
Carmustine (3.3 mg/mL), breakthrough detected at 22.9 minutes
The following chemotherapy drugs and concentration showed breakthrough detected in less than 40 minutes:
ThioTEPA (10 mg/mL), breakthrough detected at 37.1 minutes
Warning: Do not use with Carmustine or ThioTEPA
The following hazardous drugs (opioids) and concentration had NO breakthrough detected up to 240 minutes:
Fentanyl Citrate Injection (100 mcg/2 mL)
Simulated Gastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 Solution
{13}------------------------------------------------
Image /page/13/Picture/0 description: The image shows the logo for Owens & Minor. The logo consists of two parts: a red symbol on the left and the company name "Owens & Minor" in gray on the right. The red symbol is a stylized representation of the letters "OM" with horizontal lines running through them. The company name is written in a serif font, with the "&" symbol connecting the two names.
| Indications for Use for HalyardSTERLING SG* SENSI-GUARDPowder-Free Nitrile ExamGloves, Low Dermatitis Potential,Tested for use withChemotherapy Drugs, FentanylCitrate and Gastric Acid | The Halyard STERLING SG* SENSI-GUARD Powder-Free Nitrile Exam Gloves,Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, FentanylCitrate and Gastric Acid are disposable devices intended for medical purposesthat is worn on the examiner's hand to prevent contamination betweenpatient and examiner.The following chemotherapy drugs and concentration had NO breakthroughdetected up to 240 minutes:Azacitidine (Vidaza) (25 mg/mL)Bendamustine HCl (5 mg/mL)Bleomycin Sulfate (Blenoxane) (15 mg/mL)Bortezomib (Velcade) (1 mg/mL)Busulfan (6 mg/mL)Capecitabine (26 mg/mL)Carboplatin ( 10 mg/mL)Carfilzomib (2 mg/mL)Cetuximab (Erbitux) (2 mg/mL)Cisplatin (1 mg/mL)Cladribine (1 mg/mL)Cyclophosphamide (20 mg/mL)Cytarabine HCl (Cytosine) (100 mg/mL)Dacarbazine (DTIC) (10 mg/mL)Dactinomycin (0.5 mg/mL)Daunorubicin HCl (5 mg/mL)Decitabine ( 5 mg/mL)Docetaxel HCl (20 mg/mL)Doxorubicin HCl (2 mg/mL)Epirubicin HCl (Ellence) (2 mg/mL)Etoposide (20 mg/mL)Eribulin Mesylate (0.5 mg/mL)Fludarabine (25 mg/mL)5-Fluorouracil (50 mg/mL)Gemcitabine HCl (38 mg/mL)Idarubicin HCl (1 mg/mL)Ifosfamide (IFEX) (50 mg/mL)Irinotecan HCl (20 mg/mL)Lenvatinib (20 mg/mL)Leuprolide Acetate Salt (5 mg/mL)Mechlorethamine HCl (1 mg/mL)Melphalan HCl (5 mg/mL)Methotrexate (25 mg/mL)Mitomycin C (0.5 mg/mL)Mitoxantrone HCl (2 mg/mL)Oxaliplatin (5 mg/mL)Paclitaxel (Taxol) (6 mg/mL (6,000 ppm)Pemetrexed (25 mg/mL)Raltitrexed (0.5 mg/mL)Ritux1mab ( 10 mg/mL)Sorafenib Tosylate (200 mg/mL)Tamoxifen (2 mg/mL)Topotecan HCl (1 mg/mL) |
|---|---|
| ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
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Image /page/14/Picture/0 description: The image shows the logo for Owens & Minor. The logo consists of two parts: a red symbol on the left and the company name in gray on the right. The red symbol is a stylized "OM" with horizontal lines running through it, while the company name "Owens & Minor" is written in a serif font.
| Trisenox (Arsenic Trioxide) (1 mg/mL) |
|---|
| Vinblastine Sulfate (1 mg/mL) |
| Vincristine Sulfate (Oncovin) (1 mg/mL) |
| Vinorelbine (10 mg/mL) |
The following chemotherapy drugs and concentration showed breakthrough detected in less than 20 minutes:
| Carmustine (BCNU) (3.3 mg/ml), breakthrough detected at 14.8 minutes |
|---|
| ---------------------------------------------------------------------- |
The following chemotherapy drugs and concentration showed breakthrough detected in less than 30 minutes:
| ThioTEPA (10 mg/ml), breakthrough detected at 23.9 minutes |
|---|
| ------------------------------------------------------------ |
Warning: Do not use with Carmustine or ThioTEPA
The following hazardous drugs (opioids) and concentration had NO breakthrough detected up to 240 minutes:
| Fentanyl Citrate Injection (100 mcg/2 mL) |
|---|
| Simulated Gastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 Solution |
The following hazardous drugs and concentration had NO breakthrough detected up to 240 minutes:
| Cyclosporin A (100 mg/mL) |
|---|
| Cytovene (Ganciclovir) (10 mg/mL) |
| Retrovir (Zidovudine) (10 mg/mL) |
{15}------------------------------------------------
Image /page/15/Picture/0 description: The image shows the logo for Owens & Minor. The logo consists of two parts: a maroon-colored symbol on the left and the company name in gray on the right. The symbol is a stylized "OM" with horizontal lines running through it. The company name, "Owens & Minor," is written in a serif font, with the "&" symbol connecting the two names.
| Indications for Use for HalyardSTERLING NITRILE-XTRA*Powder-Free Exam Gloves, LowDermatitis Potential, Tested foruse with Chemotherapy Drugs,Fentanyl Citrate and Gastric Acid | The Halyard STERLING NITRILE-XTRA* Powder-Free Exam Gloves, LowDermatitis Potential, Tested for use with Chemotherapy Drugs, FentanylCitrate and Gastric Acid are disposable devices Intended for medical purposesthat is worn on the examiner's hand to prevent contamination betweenpatient and examiner.The following chemotherapy drugs and concentration had NO breakthroughdetected up to 240 minutes:Azacitidine (Vidaza) (25 mg/mL)Bendamustine HCl (5 mg/mL)Bleomycin Sulfate (Blenoxane) (15 mg/mL)Bortezomib (Velcade) (1 mg/mL)Busulfan (6 mg/mL)Capecitabine (26 mg/mL)Carboplatin ( 10 mg/mL)Carfilzomib (2 mg/mL)Cetuximab (Erbitux) (2 mg/mL)Cisplatin (1 mg/mL)Cladribine (1 mg/mL)Cyclophosphamide (20 mg/mL)Cytarabine HCl (Cytosine) (100 mg/mL)Dacarbazine (DTIC) (10 mg/mL)Dactinomycin (0.5 mg/mL)Daunorubicin HCl (5 mg/mL)Decitabine ( 5 mg/mL)Docetaxel HCl (20 mg/mL)Doxorubicin HCl (2 mg/mL)Epirubicin HCl (Ellence) (2 mg/mL)Etoposide (20 mg/mL)Floxuridine (100 mg/mL)Fludarabine (25 mg/mL)5-Fluorouracil (50 mg/mL)Gemcitabine HCl (38 mg/mL)Idarubicin HCl (1 mg/mL)Ifosfamide (IFEX) (50 mg/mL)Irinotecan HCl (20 mg/mL)Lenvatinib (20 mg/mL)Leuprolide Acetate Salt (5 mg/mL)Mechlorethamine HCl (1 mg/mL)Melphalan HCl (5 mg/mL)Methotrexate (25 mg/mL)Mitomycin C (0.5 mg/mL)Mitoxantrone HCl (2 mg/mL)Nelarabine (5 mg/mL)Oxaliplatin (5 mg/mL)Paclitaxel (Taxol) (6 mg/mL (6,000 ppm)Pemetrexed (25 mg/mL)Ralt1trexed (0.5 mg/mL)Rituximab ( 10 mg/mL)Sorafenib Tosylate (200 mg/mL) |
|---|---|
| ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
{16}------------------------------------------------
Image /page/16/Picture/0 description: The image shows the logo for Owens & Minor. The logo consists of the letters "OM" in a stylized, maroon-colored font on the left side. To the right of the letters is the company name "Owens & Minor" in a gray, sans-serif font. The ampersand symbol is placed between the two words.
| Tamoxifen (2 mg/mL) |
|---|
| Teniposide (10 mg/mL) |
| Topotecan HCI (1 mg/mL) |
| Trisenox (Arsenic Trioxide) (1 mg/mL) |
| Vinblastine Sulfate (1 mg/mL) |
| Vincristine Sulfate (Oncovin) (1 mg/mL) |
| Vinorelbine (10 mg/mL) |
The following chemotherapy drugs and concentration showed breakthrough detected in less than 30 minutes:
| Carmustine (3.3 mg/ml), breakthrough detected at 25.2 minutes |
|---|
| --------------------------------------------------------------- |
The following chemotherapy drugs and concentration showed breakthrough detected in less than 40 minutes:
| ThioTEPA (10 mg/ml), breakthrough detected at 35.5 minutes |
|---|
| ------------------------------------------------------------ |
Warning: Do not use with Carmustine or ThioTEPA
The following hazardous drugs (opioids) and concentration had NO breakthrough detected up to 240 minutes:
| Fentanyl Citrate Injection (100 mcg/2 mL) |
|---|
| Simulated Gastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 Solution |
| Technological Characteristics Comparison Table | |||||||
|---|---|---|---|---|---|---|---|
| Subject DeviceHalyardSTERLING*Nitrile Powder-Free Exam | Subject DeviceHalyard STERLINGSG* NITRILE Sensi-Guard Powder-Free Exam Gloves | Subject DeviceHalyardSTERLING*NITRILE-XTRA*Powder-Free | Predicate DeviceK191230 | ReferenceDeviceK192241 | Comparison | ||
| FDA ProductCode | LZA, LZC, OPJ,QDO | LZA, LZC, OPJ,QDO | LZA, LZC, OPJ,QDO | LZC | LZA, LZC, QDO | Similar | |
| FDAClassification | Class I | Class I | Class I | Class I | Class I | Same | |
| RegulationNumber | 880.6250 | 880.6250 | 880.6250 | 880.6250 | 880.6250 | Same | |
| Common Name | Medical ExamGlove | Medical ExamGlove | Medical ExamGlove | Medical ExamGlove | Medical ExamGlove | Same | |
| Device TradeName | HalyardSTERLING*Nitrile Powder-Free ExamGloves | Halyard STERLINGSG* NITRILE Sensi-Guard Powder-Free Exam Gloves | HalyardSTERLING*NITRILE-XTRA*Powder-Free ExamGloves | Halyard SterlingSG* Nitrile Sensi-Guard Powder-Free Exam GlovesHalyard SterlingNitrile Powder-Free Exam Gloves | Halyard PurpleXtra andPurple Sterile,LowDermatitisPotential,Powder-Free | Similar | |
| Intended Use | Similar | ||||||
| The device withLow DermatitisPotential,ChemotherapyDrugs, FentanylCitrate andGastric Acid is adisposabledevice intendedfor medicalpurposes that isworn on theexaminer's handto preventcontaminationbetween patientand examiner.These gloveswere tested foruse withchemotherapydrugs, fentanylcitrate andgastric acid aslisted on thelabel. | The device withLow DermatitisPotential,ChemotherapyDrugs, FentanylCitrate and GastricAcid is adisposable deviceintended formedical purposesthat is worn onthe examiner'shand to preventcontaminationbetween patientand examiner.These gloves weretested for usewithchemotherapydrugs, fentanylcitrate and gastricacid as listed onthe label. | The device withLow DermatitisPotential,ChemotherapyDrugs, FentanylCitrate and GastricAcid is adisposable deviceintended formedical purposesthat is worn onthe examiner'shand to preventcontaminationbetween patientand examiner.These gloves weretested for usewithchemotherapydrugs, fentanylcitrate and gastricacid as listed onthe label. | The devices aredisposable devicesintended formedical purposesthat is worn onthe examiner'shand to preventcontaminationbetween patientand examiner.These gloves weretested for usewithchemotherapydrugs as listed onthe label. | The devicesare disposabledevicesintended formedicalpurposes thatis worn on theexaminer'shand topreventcontaminationbetweenpatient andexaminer.These gloveswere testedfor lowdermatitispotential anduse withchemotherapydrugs andfentanylcitrate aslisted on thelabel. | |||
| TechnologicalCharacteristics | Grey- colored,9.5 inch,chlorinated,nitrile, 0.08 mmthick at palm,powder-free,texturedfingertip,ambidextrous,non-sterilepatient | Grey- colored, 9.5inch, chlorinated,nitrile, 0.08 mmthick at palm,powder-free,textured fingertip,ambidextrous,non-sterile patientexamination glove | Grey- colored, 12inch, chlorinated,nitrile, 0.09 mmthick at palm,powder-free,textured fingertip,ambidextrous,non-sterile patientexamination glove | Grey- colored, 9.5inch, nitrile, 0.08mm thick at palm,powder-free,texturedfingertips,ambidextrous,non-sterile patientexamination glove | Purple-colored, 12inch, nitrile,0.05 mm thickat palmpowder-free,texturedfingertip,ambidextrous,patientexamination | Similar | |
| Sizes of gloves | XS, S, M, L, XL | XS, S, M, L, XL | XS, S, M, L, XL | XS, S, M, L, XL | XS, S, M, L, XL | Same | |
| Glove Length | 9.5 inch | 9.5 inch | 12 inch | 9.5 inch | 12 inch | Similar | |
| Texture | Texturedfingertips | Texturedfingertips | Texturedfingertips | Texturedfingertips | Texturedfingertips | Same | |
| Sterility | Non-Sterile | Non-Sterile | Non-Sterile | Non-Sterile | Sterile | Similar | |
| Performance Data | |||||||
| Subject DeviceHalyardSTERLING* NitrilePowder-FreeExam Gloves | Subject DeviceHalyard STERLINGSG* NITRILE Sensi-Guard Powder-Free Exam Gloves | Subject DeviceHalyardSTERLING*NITRILE-XTRA*Powder-Free | Predicate DeviceK191230 | Reference DeviceK192241 | Comparison | ||
| The following | The following | The following | These gloves were | These gloves were | Similar | ||
| chemotherapy | chemotherapy | chemotherapy | tested for | tested for use with | |||
| drugs and | drugs and | drugs and | use with the | the following | |||
| concentration had | concentration had | concentration had | following | chemotherapy | |||
| NO breakthrough | NO breakthrough | NO breakthrough | chemotherapy | drugs and | |||
| detected up to | detected up to | detected up to | drugs: | Fentanyl Citrate as | |||
| 240 minutes: | 240 minutes: | 240 minutes: | Arsenic Trioxide (1 | per ASTM -D6978- | |||
| Azacitidine | Azacitidine | Azacitidine | mg/ml), No | 05 : | |||
| (Vidaza) (25 | (Vidaza) (25 | (Vidaza) (25 | breakthrough up | Aisenic Trioxide (I | |||
| mg/mL) | mg/mL) | mg/mL) | to 240 minutes | mg/ml) No | |||
| Bendamustine HCl | Bendamustine HCl | Bendamustine HCl | Doxorubicin HCL | breakthrough up | |||
| (5 mg/mL) | (5 mg/mL) | (5 mg/mL) | (2 mg/ml), No | to 240 minutes | |||
| Bleomycin Sulfate | Bleomycin Sulfate | Bleomycin Sulfate | breakthrough up | Azacitidine | |||
| (Blenoxane) (15 | (Blenoxane) (15 | (Blenoxane) (15 | to 240 minutes | (Vidaza) (25 | |||
| mg/mL) | mg/mL) | mg/mL) | Paclitaxel (6 | mg/ml) No | |||
| Bortezomib | Bortezomib | Bortezomib | mg/ml), No | breakthrough up | |||
| (Velcade) (1 | (Velcade) (1 | (Velcade) (1 | breakthrough up | to 240 minutes | |||
| mg/mL) | mg/mL) | mg/mL) | to 240 minutes | Bendamustine (5 | |||
| Busulfan (6 | Busulfan (6 | Busulfan (6 | Azacitidine | mg/ml) No | |||
| mg/mL) | mg/mL) | mg/mL) | (Vidaza) (25 | breakthrough up | |||
| Capecitabine (26 | Capecitabine (26 | Capecitabine (26 | mg/ml), No | to 240 minutes | |||
| mg/mL) | mg/mL) | mg/mL) | breakthrough up | Bortezomib | |||
| Carboplatin ( 10 | Carboplatin ( 10 | Carboplatin ( 10 | to 240 minutes | (Velcade) (1 | |||
| mg/mL) | mg/mL) | mg/mL) | Epirubicin | mg/ml) No | |||
| Carfilzomib (2 | Carfilzomib (2 | Carfilzomib (2 | (Ellence) (2 | breakthrough up | |||
| mg/mL) | mg/mL) | mg/mL) | mg/ml), No | to 240 minutes | |||
| Cetuximab | Cetuximab | Cetuximab | breakthrough up | Bleomycin sulfate | |||
| (Erbitux) (2 | (Erbitux) (2 | (Erbitux) (2 | to 240 minutes | (15 mg/ml) No | |||
| mg/mL) | mg/mL) | mg/mL) | Paraplatin (10 | breakthrough up | |||
| Cisplatin (1 | Cisplatin (1 | Cisplatin (1 | mg/ml), No | to 240 minutes | |||
| mg/mL) | mg/mL) | mg/mL) | breakthrough up | Busulfan (6 | |||
| Cladribine (1 | Cladribine (1 | Cladribine (1 | to 240 minutes | mg/ml) No | |||
| mg/mL) | mg/mL) | mg/mL) | Bendamustine (5 | breakthrough up | |||
| Cyclophosphamide | Cyclophosphamide | Cyclophosphamide | mg/ml), No | to 240 minutes | |||
| (20 mg/mL) | (20 mg/mL) | (20 mg/mL) | breakthrough up | Carboplatin (10 | |||
| Cytarabine HCl | Cytarabine HCl | Cytarabine HCl | to 240 minutes | mg/ml) No | |||
| (Cytosine) (100 | (Cytosine) (100 | (Cytosine) (100 | Eribulin Mesylate | breakthrough up | |||
| mg/mL) | mg/mL) | mg/mL) | (0.5 mg/ml), No | to 240 minutes | |||
| Dacarbazine | Dacarbazine | Dacarbazine | breakthrough up | Carfilzomib (2 | |||
| (DTIC) (10 mg/mL) | (DTIC) (10 mg/mL) | (DTIC) (10 mg/mL) | to 240 minutes | mg/ml) No | |||
| Dactinomycin (0.5 | Dactinomycin (0.5 | Dactinomycin (0.5 | Pemetrexed (25 | breakthrough up | |||
| mg/mL) | mg/mL) | mg/mL) | mg/ml), No | to 240 minutes | |||
| Daunorubicin HCl | Daunorubicin HCl | Daunorubicin HCl | breakthrough up | Carmustine (3.3 | |||
| (5 mg/mL) | (5 mg/mL) | (5 mg/mL) | to 240 minutes | mg/ml) | |||
| Decitabine ( 5 | Decitabine ( 5 | Decitabine ( 5 | Bortezomib | permeation | |||
| mg/mL) | mg/mL) | mg/mL) | (Velcade) (1 | occurred at 169.8 | |||
| Doxorubicin HCl (2 | Doxorubicin HCl (2 | Doxorubicin HCl (2 | to 240 minutes | (Erbitux) (2 | |||
| mg/mL) | mg/mL) | mg/mL) | Etoposide (20 | mg/ml) No | |||
| Docetaxel HCl (20 | Docetaxel HCl (20 | Docetaxel HCl (20 | mg/ml), No | minutes | |||
| mg/mL) | mg/mL) | mg/mL) | breakthrough up | Cetuximab |
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Image /page/17/Picture/0 description: The image shows the logo for Owens & Minor. The logo consists of two parts: a stylized "OM" in maroon color on the left and the words "Owens & Minor" in gray color on the right. The "OM" is made up of several horizontal lines, giving it a modern and abstract look. The font used for "Owens & Minor" is a serif font, which adds a touch of elegance to the logo.
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Image /page/18/Picture/0 description: The image shows the logo for Owens & Minor. The logo consists of two parts: a maroon-colored emblem on the left and the company name in gray on the right. The emblem features a stylized "OM" with horizontal lines running through it. The text "Owens & Minor" is written in a serif font, with "Owens" stacked above "& Minor".
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Image /page/19/Picture/0 description: The image shows the logo for Owens & Minor. The logo consists of the letters "OM" in a stylized font on the left, with the words "Owens & Minor" in a serif font on the right. The letters "OM" are in a dark red color, while the words "Owens & Minor" are in a light gray color. The logo is simple and modern, and it is likely used to represent the company's brand.
Epirubicin HCl (Ellence) (2 mg/mL) Etoposide (20 mg/mL) Floxuridine (1 00mg/mL) 5-Fluorouracil (50 mg/mL) Gemcitabine HCl (38 mg/mL) Idarubicin HCl (1 mg/mL) lfosfamide (IFEX) (50 mg/mL) Irinotecan HCl (20 mg/mL) Lenvatinib (20mg/mL) Leuprolide Acetate Salt (5 mg/mL) Mechlorethamine HCl (1 mg/mL) Melphalan HCl (5 mg/mL) Methotrexate (25 mg/mL) Mitomycin C (0.5 mg/mL) Mitoxantrone HCl (2 mg/mL) Nelarabine (5 mg/mL) Oxaliplatin (5 mg/mL) Paclitaxel (Taxol) (6 mg/mL (6,000 ppm) Pemetrexed (25 mg/mL) Raltitrexed (0.5 mg/mL) Sorafenib Tosylate (200 mg/mL) Streptozocin (100mg/mL) Tamoxifen (2 mg/mL) Teniposide (10 mg/mL) Topotecan HCl (1 mg/mL) Trisenox (Arsenic Trioxide) (1 mg/mL) Vinblastine Sulfate (1 mg/mL)
Epirubicin HCl (Ellence) (2 mg/mL) Etoposide (20 mg/mL) Eribulin Mesylate (0.5 mg/mL) Fludarabine (25 mg/mL) 5-Fluorouracil (50 mg/mL) Gemcitabine HCl (38 mg/mL) ldarubicin HCl (1 mg/mL) lfosfamide (IFEX) (50 mg/mL) Irinotecan HCl (20 mg/mL) Lenvatinib (20 mg/mL) Leuprolide Acetate Salt (5 mg/mL) Mechlorethamine HCl (1 mg/mL) Melphalan HCl (5 mg/mL) Methotrexate (25 mg/mL) Mitomycin C (0.5 mg/mL) Mitoxantrone HCl (2 mg/mL) Oxaliplatin (5 mg/mL) Paclitaxel (Taxol) (6 mg/mL (6,000 ppm) Pemetrexed (25 mg/mL) Raltitrexed (0.5 mg/mL) Ritux1mab ( 10 mg/mL) Sorafenib Tosylate (200 mg/mL) Tamoxifen (2 mg/mL) Topotecan HCl (1 mg/mL) Trisenox (Arsenic Trioxide) (1 mg/mL) Vinblastine Sulfate (1 mg/mL) Vincristine Sulfate (Oncovin) (1
Epirubicin HCl (Ellence) (2 mg/mL) Etoposide (20 mg/mL) Floxuridine (100 mg/mL) Fludarabine (25 mg/mL) 5-Fluorouracil (50 mg/mL) Gemcitabine HCl (38 mg/mL) Idarubicin HCl (1 mg/mL) lfosfamide (IFEX) (50 mg/mL) Irinotecan HCl (20 mg/mL) Lenvatinib (20 mg/mL) Leuprolide Acetate Salt (5 mg/mL) Mechlorethamine HCl (1 mg/mL) Melphalan HCl (5 mg/mL) Methotrexate (25 mg/mL) Mitomycin C (0.5 mg/mL) Mitoxantrone HCl (2 mg/mL) Nelarabine (5 mg/mL) Oxaliplatin (5 mg/mL) Paclitaxel (Taxol) (6 mg/mL (6,000 ppm) Pemetrexed (25 mg/mL) Ralt1trexed (0.5 mg/mL) Rituximab ( 10 mg/mL) Sorafenib Tosylate (200 mg/mL) Streptozocin (100 mg/mL) Tamoxifen (2 mg/mL) Teniposide (10 mg/mL) Topotecan HCl (1 mg/mL) Trisenox (Arsenic
mg/ml), No breakthrough up to 240 minutes Pertuzumab (30 mg/ml), No breakthrough up to 240 minutes Bleomycin sulfate (15 mg/ml), No breakthrough up to 240 minutes Fludarabine (25 mg/ml), No breakthrough up to 240 minutes Raltitrexed (0.5 mg/ml), No breakthrough up to 240 minutes Busulfan (6 mg/ml),No breakthrough up to 240 minutes Fluorouracil (50 mg/ml), No breakthrough up to 240 minutes, Retrovir (10 mg/ml) No breakthrough up to 240 minutes Carboplatin (10 mg/ml), No breakthrough up to 240 minutes Fulvestrant (50 mg/ml), No breakthrough up to 240 minutes Rituximab (10 mg/ml), No breakthrough up to 240 minutes Carfilzomib (2 mg/ml), No breakthrough up to 240 minutes Gemcitabine (38 mg/ml), No breakthrough up to 240 minutes Temsirolimus (25 mg/ml), No breakthrough up to 240 minutes Cetuximab (Erbitux) (2
breakthrough up to 240 minutes Cisplatin (I mg/ml) No breakthrough up to 240 minutes Cladtibine (1 0 mg/ml) No breakthrough up to 240 minutes Cyclophosphamide (20 mg/ml) No breakthrough up to 240 minutes Cytarabme HCL (100 mg/ml) No breakthrough up to 240 minutes Cytovene (10 mg/ml) No breakthrough up to 240 minutes Dacarbazine (10 mg/ml) No breakthrough up to 240 minutes Daunorubicin HCL (5 mg/ml) No breakthrough up to 240 minutes Decitabine (5 mg/ml) No breakthrough up to 240 minutes Docetaxel (IO mg/ml) No breakthrough up to 240 minutes Doxoiubicin HCL (2 mg/ml) No breakthrough up to 240 minutes Epnubicin (Ellence) (2 mg/ml) No breakthrough up to 240 minutes Etopos1de (20 mg/ml) No breakthrough up to 240 minutes Fludarabme (25 mg/ml) No breakthrough up to 240 minutes Fluorouracil (50 mg/ml) No breakthrough up
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Image /page/20/Picture/0 description: The image shows the logo for Owens & Minor. The logo consists of a stylized "OM" in maroon on the left, with the words "Owens & Minor" in gray on the right. The "OM" is made up of horizontal lines, giving it a modern and corporate look. The overall design is clean and professional.
| Vincristine Sulfate(Oncovin) (1mg/mL)Vinorelbine (10mg/mL)The followingchemotherapydrugs andconcentrationshowedbreakthroughdetected in lessthan 30 minutes:Carmustine (3.3mg/mL),breakthroughdetected at 22.9minutesThe followingchemotherapydrugs andconcentrationshowedbreakthroughdetected in lessthan 40 minutes:ThioTEPA (10mg/mL),breakthroughdetected at 37.1minutesWarning: Do notuse withCarmustine orThioTEPAThe followinghazardous drugs(opioids) andconcentration hadNO breakthroughdetected up to240 minutes:Fentanyl CitrateInjection (100mcg/2 mL)Simulated GastricAcidFluid/FentanylCitrate InjectionMix 50/50Solution | Vinorelbine (10mg/mL)The followingchemotherapydrugs andconcentrationshowedbreakthroughdetected in lessthan 20 minutes:Carmustine(BCNU) (3.3mg/ml),breakthroughdetected at 14.8minutesThe followingchemotherapydrugs andconcentrationshowedbreakthroughdetected in lessthan 30 minutes:ThioTEPA (10mg/ml),breakthroughdetected at 23.9minutesWarning: Do notuse withCarmustine orThioTEPAThe followinghazardous drugs(opioids) andconcentration hadNO breakthroughdetected up to240 minutes:Fentanyl CitrateInjection (100mcg/2 mL)Simulated GastricAcidFluid/FentanylCitrate InjectionMix 50/50Solution | Trioxide) (1mg/mL)Vinblastine Sulfate(1 mg/mL)Vincristine Sulfate(Oncovin) (1mg/mL)Vinorelbine (10mg/mL)The followingchemotherapydrugs andconcentrationshowedbreakthroughdetected in lessthan 30 minutes:Carmustine (3.3mg/ml),breakthroughdetected at 25.2minutesThe followingchemotherapydrugs andconcentrationshowedbreakthroughdetected in lessthan 40 minutes:ThioTEPA (10mg/ml),breakthroughdetected at 35.5minutesWarning: Do notuse withCarmustine orThioTEPAThe followinghazardous drugs(opioids) andconcentration hadNO breakthroughdetected up to240 minutes:Fentanyl CitrateInjection (100mcg/2 mL)Simulated GastricAcidFluid/Fentanyl | mg/ml), Nobreakthrough upto 240 minutesIdarubicin (1mg/ml), Nobreakthrough upto 240 minutesTrastuzumab (21mg/ml), Nobreakthrough upto 240 minutesCisplatin (1mg/ml), Nobreakthrough upto 240 minutesIfosfamide (50mg/ml), Nobreakthrough upto 240 minutesTopotecan HCL (1mg/ml), Nobreakthrough upto 240 minutesCyclophosphamide(20 mg/ml), Nobreakthrough upto 240 minutesIrinotecan (20mg/ml), Nobreakthrough upto 240 minutesTriclosan (2mg/ml), Nobreakthrough upto 240 minutesCytarabine HCL(100 mg/ml), Nobreakthrough upto 240 minutesMechlorethamineHCL (1 mg/ml), Nobreakthrough upto 240 minutesTrisonex (1mg/ml), Nobreakthrough upto 240 minutesCytovene (10mg/ml), Nobreakthrough upto 240 minutesMelphalan (5mg/ml), Nobreakthrough upto 240 minutesVincrinstine | to 240 minutesFulvestrant (50mg/ml) Nobreakthrough upto 240 minutesGemcitabine (38mg/ml) Nobreakthrough upto 240 minutesIdarubicin (1mg/ml) Nobreakthrough upto 240 minutesIfosfamide (50mg/ml) Nobreakthrough upto 240 minuteshinotecan (20mg/ml) Nobreakthrough upto 240 minutesMechlorethamineHCL (1 mg/ml) Nobreakthrough upto 240 minutesMelphalan (5mg/ml) Nobreakthrough upto 240 minutesMethotrexate (25mg/ml) Nobreakthrough upto 240 minutesMitomycin-C (0 5mg/ml) Nobreakthrough upto 240 minutesMitoxantl one (2mg/ml) Nobreakthrough upto 240 minutesOxaliplatm (2mg/ml) Nobreakthrough upto 240 minutesPachtaxel (6mg/ml) Nob1eakth10ugh upto 240 minutesParaplatm (10mg/ml) Nobreakthrough upto 240 minutesPemetrexed (25mg/ml) Nobreakthrough up |
|---|---|---|---|---|
| hazardous drugsand concentrationhad NObreakthroughdetected up to240 minutes:Cyclosporin A (100mg/mL)Cytovene(Ganciclovir) (10mg/mL)Retrovir(Zidovudine) (10mg/mL) | Mix 50/50Solution | No breakthroughup to 240 minutesFORM FDA 3881(7/17) Page 2 of 2Dacarbazine (10mg/ml), Nobreakthrough upto 240 minutesMethotrexate (25mg/ml), Nobreakthrough upto 240 minutes,Vinblastine (1mg/ml), Nobreakthrough upto 240 minutesDaunorubicin HCL(5 mg/ml), Nobreakthrough upto 240 minutesMitomycin-C (0.5mg/ml), Nobreakthrough upto 240 minutesVinorelbine (10mg/ml), Nobreakthrough upto 240 minutesDecitabine (5mg/ml), Nobreakthrough upto 240 minutesMitoxantrone (2mg/ml), Nobreakthrough upto 240 minutesZoledronic Acid(0.8 mg/ml), Nobreakthrough upto 240 minutesDocetaxel (10mg/ml), Nobreakthrough upto 240 minutesOxaliplatin (2mg/ml), Nobreakthrough upto 240 minutesThioTEPA (10mg/ml),breakthroughdetected at 37.1minutesCarmustine (3.3mg/ml),breakthrough | Pertuzumab (30mg/ml) Nobreakthrough upto 240 minutesRaltitrexed (0.5mg/ml) Nobreakthrough upto 240 minutesRetrovn (10mg/ml) Nobreakthrough upto 240 minutesRituximab (10mg/ml) Nobreakthrough upto 240 minutesTemsuolimus (25mg/ml) Nobreakthrough upto 240 minutesTiastuzumab (21mg/ml) Nobreakthrough upto 240 minutesThioTEPA (10mg/ml) Nobreakthrough upto 240 minutesTopotecan HCL (Img/ml) Nobreakthrough upto 240 minutesTriclosan (I mg/ml)No breakthroughup to 240 minutesTrisenox (0.1mg/ml) Nobreakthrough upto 240 minutesVincrinstmeSulfate (1 mg/ml)No breakthroughup to 240 minutesVinblastine (Img/ml) Nobreakthrough upto 240 minutesVinorelbine (10mg/ml) Nobreakthrough upto 240 minutesZoledronic Acid(0.8 mg/ml) Nobreakthrough upto 240 minutesFentanyl Citrate(100mcg/2ml) No | |
| minutes. | breakthrough up to 240 minutes | |||
| These gloveswere tested foruse with thefollowingchemotherapydrugs:Arsenic Trioxide (1mg/ml), Nobreakthrough upto 240 minutesDoxorubicin HCL(2 mg/ml), Nobreakthrough upto 240 minutesPaclitaxel (6mg/ml), Nobreakthrough upto 240 minutesAzacitidine(Vidaza) (25mg/ml), Nobreakthrough upto 240 minutesEpirubicin(Ellence) (2mg/ml), Nobreakthrough upto 240 minutesParaplatin (10mg/ml), Nobreakthrough upto 240 minutesBendamustine (5mg/ml), Nobreakthrough upto 240 minutesEribulin Mesylate(0.5 mg/ml), Nobreakthrough upto 240 minutesPemetrexed (25mg/ml), Nobreakthrough upto 240 minutesBortezomib(Velcade) (1mg/ml), Nobreakthrough upto 240 minutesEtoposide (20mg/ml), Nobreakthrough upto 240 minutesPertuzumab (30 |
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Image /page/21/Picture/0 description: The image shows the logo for Owens & Minor. The logo consists of the letters "OM" in a bold, maroon color, with horizontal lines running through the "O". To the right of the letters is the company name "Owens & Minor" in a gray, serif font. The logo is simple and professional, and the colors are muted and understated.
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Image /page/22/Picture/0 description: The image features the logo for Owens & Minor. On the left is a maroon-colored emblem with horizontal lines. To the right of the emblem, the text "Owens & Minor" is displayed in a serif font, with the ampersand symbol (&) connecting the two words. The text is in a light gray color.
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Image /page/23/Picture/0 description: The image shows the logo for Owens & Minor. The logo consists of the letters "OM" in a stylized font, with the word "Owens" above the word "Minor" to the right of the letters. The letters "OM" are in a dark red color, while the words "Owens & Minor" are in a light gray color. The logo is simple and modern, and it is likely used to represent the company's brand.
| breakthrough upto 240 minutesBleomycin sulfate(15 mg/ml), Nobreakthrough upto 240 minutesFludarabine (25mg/ml), Nobreakthrough upto 240 minutesRaltitrexed (0.5mg/ml), Nobreakthrough upto 240 minutesBusulfan (6mg/ml),Nobreakthrough upto 240 minutesFluorouracil (50mg/ml), Nobreakthrough upto 240 minutesRetrovir (10mg/ml) Nobreakthrough upto 240 minutesCarboplatin (10mg/ml), Nobreakthrough upto 240 minutesFulvestrant (50mg/ml), Nobreakthrough upto 240 minutesRituximab (10mg/ml), Nobreakthrough upto 240 minutesCarfilzomib (2mg/ml), Nobreakthrough upto 240 minutesGemcitabine (38mg/ml), Nobreakthrough upto 240 minutesTemsirolimus (25mg/ml), Nobreakthrough upto 240 minutesCetuximab(Erbitux) (2mg/ml), Nobreakthrough upto 240 minutesIdarubicin (1 | |||
|---|---|---|---|
| breakthrough upto 240 minutesTrastuzumab (21mg/ml), Nobreakthrough upto 240 minutesCisplatin (1mg/ml), Nobreakthrough upto 240 minutesIfosfamide (50mg/ml), Nobreakthrough upto 240 minutesTopotecan HCL (1mg/ml), Nobreakthrough upto 240 minutesCyclophosphamide(20 mg/ml), Nobreakthrough upto 240 minutesIrinotecan (20mg/ml), Nobreakthrough upto 240 minutesTriclosan (2mg/ml), Nobreakthrough upto 240 minutesCytarabine HCL(100 mg/ml), Nobreakthrough upto 240 minutesMechlorethamineHCL (1 mg/ml), Nobreakthrough upto 240 minutesTrisonex (1mg/ml), Nobreakthrough upto 240 minutesCytovene (10mg/ml), Nobreakthrough upto 240 minutesMelphalan (5mg/ml), Nobreakthrough upto 240 minutesVincrinstineSulfate (1 mg/ml),No breakthroughup to 240 minutesFORM FDA 3881(7/17) Page 2 of 2Dacarbazine (10 | |||
| mg/ml), Nobreakthrough upto 240 minutesMethotrexate (25mg/ml), Nobreakthrough upto 240 minutes,Vinblastine (1mg/ml), Nobreakthrough upto 240 minutesDaunorubicin HCL(5 mg/ml), Nobreakthrough upto 240 minutesMitomycin-C (0.5mg/ml), Nobreakthrough upto 240 minutesVinorelbine (10mg/ml), Nobreakthrough upto 240 minutesDecitabine (5mg/ml), Nobreakthrough upto 240 minutesMitoxantrone (2mg/ml), Nobreakthrough upto 240 minutesZoledronic Acid(0.8 mg/ml),Nobreakthrough upto 240 minutesDocetaxel (10mg/ml), Nobreakthrough upto 240 minutesOxaliplatin (2mg/ml), Nobreakthrough upto 240 minutesThioTEPA (10mg/ml),breakthroughdetected at 23.9minutesCarmustine (3.3mg/ml),breakthroughdetected at 14.8minutes |
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Image /page/24/Picture/0 description: The image shows the logo for Owens & Minor. The logo consists of the letters "OM" in a stylized, maroon-colored font on the left, and the words "Owens & Minor" in a gray, sans-serif font on the right. The "OM" letters are large and bold, with horizontal lines running through them.
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Image /page/25/Picture/0 description: The image shows the logo for Owens & Minor. The logo consists of the letters "OM" in a stylized font, with horizontal lines running through the "O". To the right of the letters is the company name, "Owens & Minor", in a gray sans-serif font. The letters "OM" are in a dark red color.
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Image /page/26/Picture/0 description: The image shows the logo for Owens & Minor. The logo consists of a maroon-colored symbol on the left and the words "Owens & Minor" in gray on the right. The symbol on the left appears to be a stylized "OM" with horizontal lines running through it.
PERFORMANCE CHARACTERISTICS OF THE SUBJECT DEVICE
| Performance Data | |||
|---|---|---|---|
| Subject Devices | Predicate Device | Comparison | |
| ASTM D5151-06Standard TestMethod forDetection of Holesin Medical Gloves | Testing of the subject device showsit meets the 2.5% AQL requirementin the standards for leakage. Thedevice meets the acceptancecriteria of the standard. | Testing of the predicate deviceshows it meets the 2.5% AQLrequirement in the standards forleakage. The device meets theacceptance criteria of the standard. | Same |
| ASTM D6124-06Standard TestMethod for ResidualPowder on MedicalGloves | Residual powder on the subjectdevice is within the powder-freelimit of < 2 mg maximum powderper glove and meets theacceptance criteria for powder-free. | Residual powder on the predicatedevice is within the powder-freelimit of < 2 mg maximum powderper glove and meets the acceptancecriteria for powder- free. | Same |
| ASTM D6319-10StandardSpecification forNitrile ExaminationGloves for MedicalApplications | The physical dimensions of thesubject device are within the limitsof the standard and the physicalproperties of the subject devicemet the requirements for tensilestrength before and after aging. | The physical dimensions of thepredicate device are within thelimits of the standard and thephysical properties of the subjectdevice met the requirements fortensile strength before and afteraging. | Same |
| ISO 10993-11: 2017Biologicalevaluation ofmedical devices -Tests for systemictoxicity | Under the conditions of the study,the test article did not elicit acutesystemic toxicity. | Under the conditions of the study,the test article did not elicit acutesystemic toxicity. | Same |
| ISO 10993-23: 2021BiologicalEvaluation ofMedical Devices -Part 23: Tests forIrritation | Under the conditions of the study,the test article was considered non-irritating. | Under the conditions of the study,the test article was considered non-irritating. | Same |
| ISO 10993-10: 2010Biologicalevaluation ofmedical devices -Tests for skinsensitization. | Under the conditions of the study,the test article was considered non-sensitizing. | Under the conditions of the study,the test article was considered non-sensitizing. | Same |
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Image /page/27/Picture/0 description: The image shows the logo for Owens & Minor. The logo consists of the letters "OM" in a bold, maroon color, with horizontal lines running through the letters. To the right of the letters, the words "Owens & Minor" are written in a gray, sans-serif font. The ampersand symbol is placed between the two words.
| Clinical test | A 204 subject study was completedto evaluate whether the level ofresidual chemical additives in thesubject device induced Type IVallergic contact sensitization byrepetitive applications to the skin ofnormal healthy human volunteersusing the Jordan-King modificationof the Draize test as recommendedby the FDA.Under the conditions of the study,the subject device was nonirritatingand showed no clinical evidence ofresidual chemical additives thatmay induce Type IV allergy inhuman subject | Not previously tested. | Different |
|---|---|---|---|
| Conclusion: | The conclusions drawn from the nonclinical and clinical tests demonstrate that thesubject devices Halyard STERLING* Nitrile Powder-Free Exam Gloves ,Halyard STERLING SG*NITRILE Sensi-Guard Powder-Free Exam Gloves, and Halyard STERLING* NITRILE-XTRA*Powder-Free Exam Gloves, Low Dermatitis Potential, tested for Use with ChemotherapyDrugs, Fentanyl Citrate and Gastric Acid claims, are as safe, as effective, and performs aswell as or better than the legally marketed device cleared under K191230. |
§ 880.6250 Non-powdered patient examination glove.
(a)
Identification. A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.