(266 days)
No
The device is a disposable medical glove and the summary describes its physical properties and testing against various chemicals and biological reactions. There is no mention of any software, algorithms, or data processing that would indicate the use of AI/ML.
No
The device is described as an exam glove intended to prevent contamination between the patient and examiner, not to provide therapy or treatment.
No
The device is a medical glove intended to prevent contamination, not to diagnose medical conditions or provide diagnostic information.
No
The device description clearly states it is a physical, disposable glove made of nitrile, which is a hardware component.
Based on the provided text, the device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the gloves are "worn on the examiner's hand to prevent contamination between patient and examiner." This is a barrier function for personal protection and infection control.
- IVD Definition: An In Vitro Diagnostic device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The gloves do not perform any such analysis or provide diagnostic information from patient specimens.
- Device Description: The description focuses on the physical characteristics of the gloves (material, color, texture, packaging).
- Performance Studies: The performance studies evaluate the physical properties of the gloves (leakage, powder, tensile strength) and their biological compatibility with skin (irritation, sensitization, systemic toxicity). They also test the gloves' resistance to breakthrough from certain chemicals, which relates to their barrier function, not diagnostic capability.
The testing for chemotherapy drugs and fentanyl citrate is related to the protective barrier function of the gloves when handling these substances, not for diagnosing anything in a patient.
N/A
Intended Use / Indications for Use
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) 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) 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
Product codes
LZA, LZC, OPJ, QDO
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hand
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Examiner (medical purposes)
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Type: Nonclinical and clinical tests
Sample Size: Not specified for nonclinical; 204 subjects for clinical study.
Key Results (Nonclinical):
- ASTM D5151-06 (Detection of Holes): Device meets 2.5% AQL requirement for leakage.
- ASTM D6124-06 (Residual Powder): Residual powder is
§ 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.
0
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
1
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).
2
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
3
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
4
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)
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."
5
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)
6
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
"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."
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 Summary
| was Prepared | March 22, 2024 |
|---|---|
| 510(k) Submitter | O & M Halyard, Inc. |
| 1 Edison Drive | |
| Alpharetta, GA 30005 | |
| Primary Contact for | |
| this 510(k) Submission | Caitlin Senter, MS, RAC |
| Tel: 678-221-7330 | |
| Email: caitlin.senter@hyh.com | |
| Marketed Common Name | Nitrile Powder-Free Exam Gloves |
| Device Submission Trade name | |
| and Description | 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 |
| Device Common Name | Medical Exam Gloves |
| Device Product Code
and Classification Name | LZA Class I, 21 CFR §880.6250 Patient Examination Glove
LZC Class I, 21 CFR §880.6250 Patient Examination Glove, Specialty;
OPJ Class I, 21 CFR §880.6250 Medical Gloves With Chemotherapy Labeling
Claims - Test For Use With Chemotherapy Drugs
QDO 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-Free
Exam 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 patient
examination 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 Medical
Gloves |
| | ASTM D6319-10 Standard Specification for Nitrile Examination Gloves for
Medical Applications |
| | ASTM D6124-06 Standard Test Method for Residual Powder on Medical
Gloves |
| | ASTM D6978-05 Standard Practice for Assessment of Resistance of Medical
Gloves to Permeation by Chemotherapy Drugs |
| | ISO 10993-11: 2017 Biological evaluation of medical devices – Tests for
systemic toxicity. |
| | ISO 10993-23: 2021 Biological Evaluation of Medical Devices - Part 23: Tests
for Irritation |
| | ISO 10993-10: 2010 Biological evaluation of medical devices – Tests for skin
sensitization |
| Indications for Use for Halyard
STERLING* Nitrile Powder-Free
Exam Gloves, Low Dermatitis
Potential, Tested for use with
Chemotherapy Drugs, Fentanyl
Citrate and Gastric Acid | 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 (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) |
10
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 Halyard
STERLING SG* SENSI-GUARD
Powder-Free Nitrile Exam
Gloves, Low Dermatitis Potential,
Tested for use with
Chemotherapy Drugs, Fentanyl
Citrate and Gastric Acid | 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)
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) |
| ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
14
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 Halyard
STERLING NITRILE-XTRA*
Powder-Free Exam Gloves, Low
Dermatitis Potential, Tested for
use with Chemotherapy Drugs,
Fentanyl Citrate and Gastric Acid | 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)
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 Device | |||||||
| Halyard | |||||||
| STERLING* | |||||||
| Nitrile Powder- | |||||||
| Free Exam | Subject Device | ||||||
| Halyard STERLING | |||||||
| SG* NITRILE Sensi- | |||||||
| Guard Powder- | |||||||
| Free Exam Gloves | Subject Device | ||||||
| Halyard | |||||||
| STERLING* | |||||||
| NITRILE-XTRA* | |||||||
| Powder-Free | Predicate Device | ||||||
| K191230 | Reference | ||||||
| Device | |||||||
| K192241 | Comparison | ||||||
| FDA Product | |||||||
| Code | LZA, LZC, OPJ, | ||||||
| QDO | LZA, LZC, OPJ, | ||||||
| QDO | LZA, LZC, OPJ, | ||||||
| QDO | LZC | LZA, LZC, QDO | Similar | ||||
| FDA | |||||||
| Classification | Class I | Class I | Class I | Class I | Class I | Same | |
| Regulation | |||||||
| Number | 880.6250 | 880.6250 | 880.6250 | 880.6250 | 880.6250 | Same | |
| Common Name | Medical Exam | ||||||
| Glove | Medical Exam | ||||||
| Glove | Medical Exam | ||||||
| Glove | Medical Exam | ||||||
| Glove | Medical Exam | ||||||
| Glove | Same | ||||||
| Device Trade | |||||||
| Name | Halyard | ||||||
| STERLING* | |||||||
| Nitrile Powder- | |||||||
| Free Exam | |||||||
| Gloves | Halyard STERLING | ||||||
| SG* NITRILE Sensi- | |||||||
| Guard Powder- | |||||||
| Free Exam Gloves | Halyard | ||||||
| STERLING* | |||||||
| NITRILE-XTRA* | |||||||
| Powder-Free Exam | |||||||
| Gloves | Halyard Sterling | ||||||
| SG* Nitrile Sensi- | |||||||
| Guard Powder- | |||||||
| Free Exam Gloves | |||||||
| Halyard Sterling | |||||||
| Nitrile Powder- | |||||||
| Free Exam Gloves | Halyard Purple | ||||||
| Xtra and | |||||||
| Purple Sterile, | |||||||
| Low | |||||||
| Dermatitis | |||||||
| Potential, | |||||||
| Powder-Free | Similar | ||||||
| Intended Use | Similar | ||||||
| The device with | |||||||
| Low Dermatitis | |||||||
| Potential, | |||||||
| Chemotherapy | |||||||
| Drugs, Fentanyl | |||||||
| Citrate and | |||||||
| Gastric Acid is a | |||||||
| disposable | |||||||
| device intended | |||||||
| for medical | |||||||
| purposes that is | |||||||
| worn on the | |||||||
| examiner's hand | |||||||
| to prevent | |||||||
| contamination | |||||||
| between patient | |||||||
| and examiner. |
These gloves
were tested for
use with
chemotherapy
drugs, fentanyl
citrate and
gastric acid as
listed on the
label. | The device with
Low Dermatitis
Potential,
Chemotherapy
Drugs, Fentanyl
Citrate and Gastric
Acid is a
disposable device
intended for
medical purposes
that is worn on
the examiner's
hand to prevent
contamination
between patient
and examiner.
These gloves were
tested for use
with
chemotherapy
drugs, fentanyl
citrate and gastric
acid as listed on
the label. | The device with
Low Dermatitis
Potential,
Chemotherapy
Drugs, Fentanyl
Citrate and Gastric
Acid is a
disposable device
intended for
medical purposes
that is worn on
the examiner's
hand to prevent
contamination
between patient
and examiner.
These gloves were
tested for use
with
chemotherapy
drugs, fentanyl
citrate and gastric
acid as listed on
the label. | The devices are
disposable devices
intended for
medical purposes
that is worn on
the examiner's
hand to prevent
contamination
between patient
and examiner.
These gloves were
tested for use
with
chemotherapy
drugs as listed on
the label. | The devices
are disposable
devices
intended for
medical
purposes that
is worn on the
examiner's
hand to
prevent
contamination
between
patient and
examiner.
These gloves
were tested
for low
dermatitis
potential and
use with
chemotherapy
drugs and
fentanyl
citrate as
listed on the
label. | | |
| Technological
Characteristics | Grey- colored,
9.5 inch,
chlorinated,
nitrile, 0.08 mm
thick at palm,
powder-free,
textured
fingertip,
ambidextrous,
non-sterile
patient | Grey- colored, 9.5
inch, chlorinated,
nitrile, 0.08 mm
thick at palm,
powder-free,
textured fingertip,
ambidextrous,
non-sterile patient
examination glove | Grey- colored, 12
inch, chlorinated,
nitrile, 0.09 mm
thick at palm,
powder-free,
textured fingertip,
ambidextrous,
non-sterile patient
examination glove | Grey- colored, 9.5
inch, nitrile, 0.08
mm thick at palm,
powder-free,
textured
fingertips,
ambidextrous,
non-sterile patient
examination glove | Purple-
colored, 12
inch, nitrile,
0.05 mm thick
at palm
powder-free,
textured
fingertip,
ambidextrous,
patient
examination | 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 | Textured
fingertips | Textured
fingertips | Textured
fingertips | Textured
fingertips | Textured
fingertips | Same | |
| Sterility | Non-Sterile | Non-Sterile | Non-Sterile | Non-Sterile | Sterile | Similar | |
| Performance Data | | | | | | | |
| Subject Device
Halyard
STERLING* Nitrile
Powder-Free
Exam Gloves | Subject Device
Halyard STERLING
SG* NITRILE Sensi-
Guard Powder-
Free Exam Gloves | Subject Device
Halyard
STERLING*
NITRILE-XTRA*
Powder-Free | Predicate Device
K191230 | Reference Device
K192241 | 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 | | |
17
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.
18
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".
19
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
20
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) (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 | 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 | 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 | mg/ml), No
breakthrough up
to 240 minutes
Idarubicin (1
mg/ml), No
breakthrough up
to 240 minutes
Trastuzumab (21
mg/ml), No
breakthrough up
to 240 minutes
Cisplatin (1
mg/ml), No
breakthrough up
to 240 minutes
Ifosfamide (50
mg/ml), No
breakthrough up
to 240 minutes
Topotecan HCL (1
mg/ml), No
breakthrough up
to 240 minutes
Cyclophosphamide
(20 mg/ml), No
breakthrough up
to 240 minutes
Irinotecan (20
mg/ml), No
breakthrough up
to 240 minutes
Triclosan (2
mg/ml), No
breakthrough up
to 240 minutes
Cytarabine HCL
(100 mg/ml), No
breakthrough up
to 240 minutes
Mechlorethamine
HCL (1 mg/ml), No
breakthrough up
to 240 minutes
Trisonex (1
mg/ml), No
breakthrough up
to 240 minutes
Cytovene (10
mg/ml), No
breakthrough up
to 240 minutes
Melphalan (5
mg/ml), No
breakthrough up
to 240 minutes
Vincrinstine | to 240 minutes
Fulvestrant (50
mg/ml) No
breakthrough up
to 240 minutes
Gemcitabine (38
mg/ml) No
breakthrough up
to 240 minutes
Idarubicin (1
mg/ml) No
breakthrough up
to 240 minutes
Ifosfamide (50
mg/ml) No
breakthrough up
to 240 minutes
hinotecan (20
mg/ml) No
breakthrough up
to 240 minutes
Mechlorethamine
HCL (1 mg/ml) No
breakthrough up
to 240 minutes
Melphalan (5
mg/ml) No
breakthrough up
to 240 minutes
Methotrexate (25
mg/ml) No
breakthrough up
to 240 minutes
Mitomycin-C (0 5
mg/ml) No
breakthrough up
to 240 minutes
Mitoxantl one (2
mg/ml) No
breakthrough up
to 240 minutes
Oxaliplatm (2
mg/ml) No
breakthrough up
to 240 minutes
Pachtaxel (6
mg/ml) No
b1eakth10ugh up
to 240 minutes
Paraplatm (10
mg/ml) No
breakthrough up
to 240 minutes
Pemetrexed (25
mg/ml) No
breakthrough up |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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) | Mix 50/50
Solution | No breakthrough
up to 240 minutes
FORM FDA 3881
(7/17) Page 2 of 2
Dacarbazine (10
mg/ml), No
breakthrough up
to 240 minutes
Methotrexate (25
mg/ml), No
breakthrough up
to 240 minutes,
Vinblastine (1
mg/ml), No
breakthrough up
to 240 minutes
Daunorubicin HCL
(5 mg/ml), No
breakthrough up
to 240 minutes
Mitomycin-C (0.5
mg/ml), No
breakthrough up
to 240 minutes
Vinorelbine (10
mg/ml), No
breakthrough up
to 240 minutes
Decitabine (5
mg/ml), No
breakthrough up
to 240 minutes
Mitoxantrone (2
mg/ml), No
breakthrough up
to 240 minutes
Zoledronic Acid
(0.8 mg/ml), No
breakthrough up
to 240 minutes
Docetaxel (10
mg/ml), No
breakthrough up
to 240 minutes
Oxaliplatin (2
mg/ml), No
breakthrough up
to 240 minutes
ThioTEPA (10
mg/ml),
breakthrough
detected at 37.1
minutes
Carmustine (3.3
mg/ml),
breakthrough | Pertuzumab (30
mg/ml) No
breakthrough up
to 240 minutes
Raltitrexed (0.5
mg/ml) No
breakthrough up
to 240 minutes
Retrovn (10
mg/ml) No
breakthrough up
to 240 minutes
Rituximab (10
mg/ml) No
breakthrough up
to 240 minutes
Temsuolimus (25
mg/ml) No
breakthrough up
to 240 minutes
Tiastuzumab (21
mg/ml) No
breakthrough up
to 240 minutes
ThioTEPA (10
mg/ml) No
breakthrough up
to 240 minutes
Topotecan HCL (I
mg/ml) No
breakthrough up
to 240 minutes
Triclosan (I mg/ml)
No breakthrough
up to 240 minutes
Trisenox (0.1
mg/ml) No
breakthrough up
to 240 minutes
Vincrinstme
Sulfate (1 mg/ml)
No breakthrough
up to 240 minutes
Vinblastine (I
mg/ml) No
breakthrough up
to 240 minutes
Vinorelbine (10
mg/ml) No
breakthrough up
to 240 minutes
Zoledronic Acid
(0.8 mg/ml) No
breakthrough up
to 240 minutes
Fentanyl Citrate
(100mcg/2ml) No | |
| | | minutes. | breakthrough up to 240 minutes | |
| | | These gloves
were tested for
use with the
following
chemotherapy
drugs:
Arsenic Trioxide (1
mg/ml), No
breakthrough up
to 240 minutes
Doxorubicin HCL
(2 mg/ml), No
breakthrough up
to 240 minutes
Paclitaxel (6
mg/ml), No
breakthrough up
to 240 minutes
Azacitidine
(Vidaza) (25
mg/ml), No
breakthrough up
to 240 minutes
Epirubicin
(Ellence) (2
mg/ml), No
breakthrough up
to 240 minutes
Paraplatin (10
mg/ml), No
breakthrough up
to 240 minutes
Bendamustine (5
mg/ml), No
breakthrough up
to 240 minutes
Eribulin Mesylate
(0.5 mg/ml), No
breakthrough up
to 240 minutes
Pemetrexed (25
mg/ml), No
breakthrough up
to 240 minutes
Bortezomib
(Velcade) (1
mg/ml), No
breakthrough up
to 240 minutes
Etoposide (20
mg/ml), No
breakthrough up
to 240 minutes
Pertuzumab (30 | | |
21
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.
22
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.
23
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 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
mg/ml), No
breakthrough up
to 240 minutes
| Idarubicin (1 | |||
|---|---|---|---|
| breakthrough up | |||
| to 240 minutes | |||
| Trastuzumab (21 | |||
| mg/ml), No | |||
| breakthrough up | |||
| to 240 minutes | |||
| Cisplatin (1 | |||
| mg/ml), No | |||
| breakthrough up | |||
| to 240 minutes | |||
| Ifosfamide (50 | |||
| mg/ml), No | |||
| breakthrough up | |||
| to 240 minutes | |||
| Topotecan HCL (1 | |||
| mg/ml), No | |||
| breakthrough up | |||
| to 240 minutes | |||
| Cyclophosphamide | |||
| (20 mg/ml), No | |||
| breakthrough up | |||
| to 240 minutes | |||
| Irinotecan (20 | |||
| mg/ml), No | |||
| breakthrough up | |||
| to 240 minutes | |||
| Triclosan (2 | |||
| mg/ml), No | |||
| breakthrough up | |||
| to 240 minutes | |||
| Cytarabine HCL | |||
| (100 mg/ml), No | |||
| breakthrough up | |||
| to 240 minutes | |||
| Mechlorethamine | |||
| HCL (1 mg/ml), No | |||
| breakthrough up | |||
| to 240 minutes | |||
| Trisonex (1 | |||
| mg/ml), No | |||
| breakthrough up | |||
| to 240 minutes | |||
| Cytovene (10 | |||
| mg/ml), No | |||
| breakthrough up | |||
| to 240 minutes | |||
| Melphalan (5 | |||
| mg/ml), No | |||
| breakthrough up | |||
| to 240 minutes | |||
| Vincrinstine | |||
| Sulfate (1 mg/ml), | |||
| No breakthrough | |||
| up to 240 minutes | |||
| FORM FDA 3881 | |||
| (7/17) Page 2 of 2 | |||
| Dacarbazine (10 | |||
| mg/ml), No | |||
| breakthrough up | |||
| to 240 minutes | |||
| Methotrexate (25 | |||
| mg/ml), No | |||
| breakthrough up | |||
| to 240 minutes, | |||
| Vinblastine (1 | |||
| mg/ml), No | |||
| breakthrough up | |||
| to 240 minutes | |||
| Daunorubicin HCL | |||
| (5 mg/ml), No | |||
| breakthrough up | |||
| to 240 minutes | |||
| Mitomycin-C (0.5 | |||
| mg/ml), No | |||
| breakthrough up | |||
| to 240 minutes | |||
| Vinorelbine (10 | |||
| mg/ml), No | |||
| breakthrough up | |||
| to 240 minutes | |||
| Decitabine (5 | |||
| mg/ml), No | |||
| breakthrough up | |||
| to 240 minutes | |||
| Mitoxantrone (2 | |||
| mg/ml), No | |||
| breakthrough up | |||
| to 240 minutes | |||
| Zoledronic Acid | |||
| (0.8 mg/ml),No | |||
| breakthrough up | |||
| to 240 minutes | |||
| Docetaxel (10 | |||
| mg/ml), No | |||
| breakthrough up | |||
| to 240 minutes | |||
| Oxaliplatin (2 | |||
| mg/ml), No | |||
| breakthrough up | |||
| to 240 minutes | |||
| ThioTEPA (10 | |||
| mg/ml), | |||
| breakthrough | |||
| detected at 23.9 | |||
| minutes | |||
| Carmustine (3.3 | |||
| mg/ml), | |||
| breakthrough | |||
| detected at 14.8 | |||
| minutes |
24
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.
25
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.
26
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 D5151-06 | |||
| Standard Test | |||
| Method for | |||
| Detection of Holes | |||
| in Medical Gloves | Testing of the subject device shows | ||
| it meets the 2.5% AQL requirement | |||
| in the standards for leakage. The | |||
| device meets the acceptance | |||
| criteria of the standard. | Testing of the predicate device | ||
| shows it meets the 2.5% AQL | |||
| requirement in the standards for | |||
| leakage. The device meets the | |||
| acceptance criteria of the standard. | Same | ||
| ASTM D6124-06 | |||
| Standard Test | |||
| Method for Residual | |||
| Powder on Medical | |||
| Gloves | Residual powder on the subject | ||
| device is within the powder-free | |||
| limit of |