(88 days)
Halyard Purple Nitrile* Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid are disposable devices intended for medical purposes that are worn on the examiner's hand to prevent contamination between patient and examiner. These gloves were tested for use with the following chemotherapy drugs and Fentanyl Citrate and Gastric Acid as per ASTM -D6978-05 :
The following chemotherapy drugs and concentration had NO breakthrough detected up to 240 minutes: Azacitidine (25 mg/ml) Bendamustine HCl (5 mg/ml) Bleomycin Sulfate (15 mg/ml) Bortezomib (1 mg/ml) Busulfan (6 mg/ml) Capecitabine (26 mg/ml) Carboplatin (10 mg/ml) Carlzomib (2 mg/ml) Cetuximab (2 mg/ml) Chloroquine (50 mg/ml) Cisplatin (1 mg/ml) Cladribine (1 mg/ml) Cyclophosphamide (20 mg/ml) Cyclosporin A (100 mg/ml) Cytarabine (Cytosine) (100 mg/ml) Cytovene (Ganciclovir) (10 mg/ml) Dacarbazine (DTIC) (10 mg/ml) Dactinomycin (0.5 mg/ml) Daunorubicin HCl (5 mg/ml) Decitabine (5 mg/ml) Docetaxel (10 mg/ml) Doxorubicin HCl (2 mg/ml) Epirubicin HCl (Ellence) (2 mg/ml) Etoposide (Toposar) (20 mg/ml) Fludarabine (25 mg/ml) 5-Fluorouracil (50 mg/ml) Fulvestrant (50 mg/ml) Gemcitabine (38 mg/ml) Idarubicin (1 mg/ml) Ifosfamide (50 mg/ml) Irinotecan HCl (20 mg/ml) Leuprolide Acetate Salt (5 mg/ml) Mechlorethamine HCl (1 mg/ml) Melphalan (5 mg/ml) Methotrexate (25 mg/ml) Mitomycin C (0.5 mg/ml) Mitoxantrone (2 mg/ml) Oxaliplatin (5 mg/ml) Paclitaxel (6 mg/ml) Pemetrexed (25 mg/ml) Raltitrexed (0.5 mg/ml) Retrovir (10 mg/ml) Rituximab (10 mg/ml) Temsirolimus (25 mg/ml) Topotecan HCl (1 mg/ml) Triclosan (2 mg/ml) Trisenox (1 mg/ml) Vinblastine Sulfate (1 mg/ml) Vincristine (1 mg/ml) Vinorelbine (10 mg/ml) Zoledronic Acid (0.8 mg/ml)
The following chemotherapy drugs and concentration showed breakthrough detected in less than 90 minutes: Carmustine (3.3 mg/ml) No breakthrough up to 55.3 minutes. Thiotepa (10 mg/ml) No breakthrough up to 78.8 minutes. Warning- Not for use with Carmustine and 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) (50 mcg/2 ml)
The Halyard Purple Nitrile* Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid are disposable, 9.5 " purple-colored, chlorinated, nitrile, powder-free, textured fingertip, ambidextrous, non-sterile patient examination gloves.
Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Device: Halyard Purple Nitrile* Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid (K241909).
1. Table of Acceptance Criteria and Reported Device Performance:
| Test | Standard | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Dimensions | ASTM D 6319 | Length ≥230 mm | Meets requirements |
| Palm Width: XS: 60-80mm, S: 70-90mm, M: 85-105mm, L: 100-120mm, XL: 110-130mm, XXL: 120-140mm | Meets requirements | ||
| Finger, Palm, Cuff thickness ≥0.05 mm | Meets requirements | ||
| Physical Properties | ASTM D 6319 | AQL 4.0 | Meets requirements |
| Before Aging: Tensile Strength: ≥14 MPa, Ultimate elongation: ≥500% | Meets requirements | ||
| After Aging: Tensile Strength: ≥14 MPa, Ultimate elongation: ≥400% | Meets requirements | ||
| Freedom from Pinholes | ASTM D 6319, ASTM D 5151 | AQL 2.5%, No leakage | Meets requirements |
| Powder Free | ASTM D 6124, ASTM D 6319 | ≤ 2 mg / glove | Meets requirements (average of 0.4 mg/glove) |
| Test for irritation | ISO 10993, Part 23 | Grade 1 | Under the conditions of the study, the device is not an irritant. |
| Test for acute systemic toxicity | ISO 10993, Part 11 | No animals treated with test extracts exhibit greater reaction than control animals. | Under the conditions of the study, no evidence of acute systemic toxicity. |
| Test for skin sensitization | ISO 10993, Part 10 | Grade < 1.0 | Under the conditions of the study, the device is not a sensitizer. |
| Resistance to Permeation by Chemotherapy Drugs and Hazardous Drugs (opioids) | ASTM D6978-05 | No breakthrough for up to 240 minutes for listed drugs | No signs of breakthrough for the subject device for 53 chemotherapy drugs, Fentanyl Citrate Injection (100 mcg/2ml), and Simulated Gastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 Solution. |
| Minimum breakthrough detection time for specified drugs | Carmustine 3.3mg/ml minimum breakthrough detection time is 55.3 minutes. Thiotepa 10mg/ml minimum breakthrough detection time is 78.8 minutes. (Also notes "Warning- Not for use with Carmustine and ThioTEPA") | ||
| Low Dermatitis Potential (Clinical Test) | Modified DRAIZE-95 Test (Jordan-King modification, FDA recommended) | No induced Type IV allergic contact sensitization by repetitive applications to the skin of normal healthy human volunteers. | Under the conditions of the study, the subject device was nonirritating and showed no clinical evidence of residual chemical additives that may induce Type IV allergy in human subjects. |
2. Sample Size Used for the Test Set and Data Provenance:
- Chemotherapy/Hazardous Drug Permeation and Physical Property Tests: The document does not specify the exact sample sizes used for these tests (e.g., number of gloves tested for each drug or physical attribute). The provenance is implied to be laboratory testing conducted by the manufacturer or a contracted lab.
- Low Dermatitis Potential Clinical Test: A 204 subject study was completed. The provenance is from "normal healthy human volunteers," implying a prospective clinical study specifically for this device. The country of origin is not explicitly stated.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- For the technical and performance testing (ASTM, ISO standards), the "ground truth" is established by the specifications within those recognized standards themselves. The document does not mention the use of experts to establish ground truth for the test set results, but rather relies on the test methods and acceptance criteria defined by the standards.
- For the clinical study on low dermatitis potential, the assessment of "nonirritating" and "no clinical evidence of residual chemical additives that may induce Type IV allergy" serves as the ground truth. This assessment would typically be made by qualified medical professionals (e.g., dermatologists or clinicians experienced in allergy patch testing) overseeing the study, but their specific number and qualifications are not detailed in the provided text.
4. Adjudication Method for the Test Set:
- The document does not describe an explicit adjudication method (like 2+1 or 3+1) for any of the tests. The tests performed are objective laboratory measurements (e.g., breakthrough time, tensile strength, weight of powder, visual inspection for pinholes, and clinical assessment of skin reactions). The results of these tests are directly compared against predefined acceptance criteria. For the clinical study, the "Jordan-King modification of the Draize test as recommended by the FDA" implies a standardized, objective evaluation method for skin irritation and sensitization.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This device is a medical exam glove, not an AI-powered diagnostic or assistive technology that involves "human readers" or "AI assistance" in the sense of image interpretation or similar cognitive tasks. Therefore, an MRMC comparative effectiveness study regarding improvement with AI assistance is not relevant or described.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical medical device (glove), not an algorithm or software.
7. The Type of Ground Truth Used:
- Expert Consensus/Standardized Methods:
- For the permeation tests, physical properties, pinhole detection, and powder content, the ground truth is based on established industry standards (ASTM, ISO) with defined methodologies and acceptance criteria.
- For biocompatibility (irritation, systemic toxicity, sensitization), the ground truth is established by the methods outlined in ISO 10993 parts and clinical assessment in the Low Dermatitis Potential study. The clinical assessment is based on observations and evaluations by clinical personnel in accordance with the Modified DRAIZE-95 test.
8. The Sample Size for the Training Set:
- Not applicable. This device is a physical medical device (glove) that undergoes laboratory and clinical performance testing, not a machine learning model that requires a training set. The term "training set" is generally used in the context of AI/ML development.
9. How the Ground Truth for the Training Set was Established:
- Not applicable. As stated above, this device does not utilize a training set in the AI/ML context.
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Image /page/0/Picture/0 description: The image shows 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, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 27, 2024
O&M Halyard, Inc. Caitlin Senter Director. Global Regulatory Affairs 9120 Lockwood Blvd Mechanicsville, Virginia 23116
Re: K241909
Trade/Device Name: Halyard Purple Nitrile* Powder-Free Exam Gloves, Low Dermatitis Potential. Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated 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, ODO Dated: June 30, 2024 Received: July 1, 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 Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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-regulatory
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assistance/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).
Sincerely,
Allan Guan -S
For Bifeng Qian, M.D., Ph.D. Assistant Director DHT4C: Division of Infection Control 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) K241909
Device Name
Halyard Purple Nitrile* Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid
Indications for Use (Describe)
Halyard Purple Nitrile* Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid are disposable devices intended for medical purposes that are worn on the examiner's hand to prevent contamination between patient and examiner. These gloves were tested for use with the following chemotherapy drugs and Fentanyl Citrate and Gastric Acid as per ASTM -D6978-05 :
The following chemotherapy drugs and concentration had NO breakthrough detected up to 240 minutes: Azacitidine (25 mg/ml) Bendamustine HCl (5 mg/ml) Bleomycin Sulfate (15 mg/ml) Bortezomib (1 mg/ml) Busulfan (6 mg/ml) Capecitabine (26 mg/ml) Carboplatin (10 mg/ml) Carlzomib (2 mg/ml) Cetuximab (2 mg/ml) Chloroquine (50 mg/ml) Cisplatin (1 mg/ml) Cladribine (1 mg/ml) Cyclophosphamide (20 mg/ml) Cyclosporin A (100 mg/ml) Cytarabine (Cytosine) (100 mg/ml) Cytovene (Ganciclovir) (10 mg/ml) Dacarbazine (DTIC) (10 mg/ml) Dactinomycin (0.5 mg/ml) Daunorubicin HCl (5 mg/ml) Decitabine (5 mg/ml) Docetaxel (10 mg/ml) Doxorubicin HCl (2 mg/ml) Epirubicin HCl (Ellence) (2 mg/ml) Etoposide (Toposar) (20 mg/ml) Fludarabine (25 mg/ml) 5-Fluorouracil (50 mg/ml) Fulvestrant (50 mg/ml) Gemcitabine (38 mg/ml) Idarubicin (1 mg/ml) Ifosfamide (50 mg/ml) Irinotecan HCl (20 mg/ml) Leuprolide Acetate Salt (5 mg/ml) Mechlorethamine HCl (1 mg/ml) Melphalan (5 mg/ml) Methotrexate (25 mg/ml) Mitomycin C (0.5 mg/ml) FORM FDA 3881 (8/23)
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Mitoxantrone (2 mg/ml) Oxaliplatin (5 mg/ml) Paclitaxel (6 mg/ml) Pemetrexed (25 mg/ml) Raltitrexed (0.5 mg/ml) Retrovir (10 mg/ml) Rituximab (10 mg/ml) Temsirolimus (25 mg/ml) Topotecan HCl (1 mg/ml) Triclosan (2 mg/ml) Trisenox (1 mg/ml) Vinblastine Sulfate (1 mg/ml) Vincristine (1 mg/ml) Vinorelbine (10 mg/ml) Zoledronic Acid (0.8 mg/ml)
The following chemotherapy drugs and concentration showed breakthrough detected in less than 90 minutes: Carmustine (3.3 mg/ml) No breakthrough up to 55.3 minutes. Thiotepa (10 mg/ml) No breakthrough up to 78.8 minutes. Warning- Not for use with Carmustine and 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) (50 mcg/2 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)
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Image /page/5/Picture/0 description: The image shows the logo for Owens & Minor. The logo consists of the letters "OM" in a dark red color on the left side of the image. To the right of the letters is the company name "Owens & Minor" in a light gray color.
510(k) Summary for K241909
This summary of 510(k) K241909 is being submitted in accordance with 21 CFR 807.92.
| Date Summary was Prepared | September 27, 2024 |
|---|---|
| 510(k) Submitter | O & M Halyard, Inc.9120 Lockwood BoulevardMechanicsville, VA 231161 |
| Primary Contact forthis 510(k) Submission | Caitlin Senter, MS, RACTel: 678-221-7330Email: caitlin.senter@owens-minor.com |
| Marketed Device Trade Name | Halyard Purple Nitrile* Powder-Free Exam Gloves, Low Dermatitis Potential,Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated GastricAcid and Fentanyl in Simulated Gastric Acid |
| Device Submission Trade nameand Description | Halyard Purple Nitrile* Powder-Free Exam Gloves, Low Dermatitis Potential,Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated GastricAcid and Fentanyl in Simulated Gastric 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 medical glove, specialtyOPJ 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 Purple Nitrile, Powder-Free Exam Gloves Tested for Use withChemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl inSimulated Gastric Acid (K213929) |
| Reference Device | Halyard Lavender Nitrile, Low Dermatitis Potential, Powder-Free Exam GlovesTested for Use with Chemotherapy Drugs, Fentanyl Citrate and SimulatedGastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 Solution (K213937) |
| Subject Device Description | The Halyard Purple Nitrile* Powder-Free Exam Gloves, Low DermatitisPotential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate,Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid are disposable,9.5 " purple-colored, chlorinated, nitrile, powder-free, textured fingertip,ambidextrous, non-sterile patient examination gloves. |
| Indications for Use | Halyard Purple Nitrile* Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid are disposable devices intended for medical purposes that are worn on the examiner's hand to prevent contamination between patient and examiner. These gloves were tested for use with the following chemotherapy drugs and Fentanyl Citrate and Gastric Acid as per ASTM -D6978-05:The following chemotherapy drugs and concentration had NO breakthrough detected up to 240 minutes:Azacitidine (25 mg/ml)Bendamustine HCl (5 mg/ml)Bleomycin Sulfate (15 mg/ml)Bortezomib (1 mg/ml)Busulfan (6 mg/ml)Capecitabine (26 mg/ml)Carboplatin (10 mg/ml)Carlzomib (2 mg/ml)Cetuximab (2 mg/ml)Chloroquine (50 mg/ml)Cisplatin (1 mg/ml)Cladribine (1 mg/ml)Cyclophosphamide (20 mg/ml)Cyclosporin A (100 mg/ml)Cytarabine (Cytosine) (100 mg/ml)Cytovene (Ganciclovir) (10 mg/ml)Dacarbazine (DTIC) (10 mg/ml)Dactinomycin (0.5 mg/ml)Daunorubicin HCl (5 mg/ml)Decitabine (5 mg/ml)Docetaxel (10 mg/ml)Doxorubicin HCl (2 mg/ml)Epirubicin HCl (Ellence) (2 mg/ml)Etoposide (Toposar) (20 mg/ml)Fludarabine (25 mg/ml)5-Fluorouracil (50 mg/ml)Fulvestrant (50 mg/ml)Gemcitabine (38 mg/ml)Idarubicin (1 mg/ml)Ifosfamide (50 mg/ml)Irinotecan HCl (20 mg/ml)Leuprolide Acetate Salt (5 mg/ml)Mechlorethamine HCl (1 mg/ml)Melphalan (5 mg/ml)Methotrexate (25 mg/ml)Mitomycin C (0.5 mg/ml)Mitoxantrone (2 mg/ml)Oxaliplatin (5 mg/ml)Paclitaxel (6 mg/ml) |
| Pemetrexed (25 mg/ml) | |
| Raltitrexed (0.5 mg/ml) | |
| Retrovir (10 mg/ml) | |
| Rituximab (10 mg/ml) | |
| Temsirolimus (25 mg/ml) | |
| Topotecan HCl (1 mg/ml) | |
| Triclosan (2 mg/ml) | |
| Trisenox (1 mg/ml) | |
| Vinblastine Sulfate (1 mg/ml) | |
| Vincristine (1 mg/ml) | |
| Vinorelbine (10 mg/ml) | |
| Zoledronic Acid (0.8 mg/ml) | |
| The following chemotherapy drugs and concentration showed breakthrough | |
| detected in less than 90 minutes: | |
| Carmustine (3.3 mg/ml) No breakthrough up to 55.3 minutes. | |
| Thiotepa (10 mg/ml) No breakthrough up to 78.8 minutes. | |
| Warning- Not for use with Carmustine and 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 |
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Image /page/6/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 is the company name "Owens & Minor" in a light gray color. The font is sans-serif and the overall design is clean and professional.
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Image /page/7/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 gray color. The ampersand symbol is placed between the two words.
| Technological Characteristics Comparison Table | ||||
|---|---|---|---|---|
| Subject Device(K241909) | Predicate Device(K213929) | Reference Device(K213937) | Comparison | |
| FDA Product Code | LZA, LZC, OPJ, QDO | LZA, OPJ, QDO | LZA, LZC, QDO | Similar |
| FDA Classification | Class I | Class I | Class I | Same |
| Regulation Number | 880.6250 | 880.6250 | 880.6250 | Same |
| Common Name | Medical Exam Glove | Medical Exam Glove | Medical Exam Glove | Same |
| Device Trade Name | Halyard Purple Nitrile*Powder-Free ExamGloves, Low DermatitisPotential, Tested forUse withChemotherapy Drugs,Fentanyl Citrate,Simulated Gastric Acidand Fentanyl inSimulated Gastric Acid | Halyard Purple Nitrile,Powder-Free Exam GlovesTested for Use withChemotherapy Drugs,Fentanyl Citrate,Simulated Gastric Acidand Fentanyl in SimulatedGastric Acid | Halyard LavenderNitrile, Low DermatitisPotential, Powder-FreeExam Gloves Testedfor Use withChemotherapy Drugs,Fentanyl Citrate andSimulated Gastric AcidFluid/Fentanyl CitrateInjection Mix 50/50Solution | Similar |
| IntendedUse/Indications forUse | Halyard Purple Nitrile*Powder-Free ExamGloves, Low DermatitisPotential, Tested forUse with ChemotherapyDrugs, Fentanyl Citrate,Simulated Gastric Acidand Fentanyl inSimulated Gastric Acidare disposable devicesintended for medicalpurposes that are wornon the examiner's handto preventcontamination betweenpatient and examiner.These gloves weretested for use with thefollowing chemotherapydrugs and FentanylCitrate and Gastric Acidas per ASTM -D6978-05:The followingchemotherapy drugsand concentration hadNO breakthroughdetected up to 240minutes:Azacitidine (25 mg/ml)Bendamustine HCl (5mg/ml)Bleomycin Sulfate (15mg/ml)Bortezomib (1 mg/ml)Busulfan (6 mg/ml)Capecitabine (26mg/ml)Carboplatin (10 mg/ml)Carlzomib (2 mg/ml)Cetuximab (2 mg/ml)Chloroquine (50 mg/ml)Cisplatin (1 mg/ml)Cladribine (1 mg/ml)Cyclophosphamide (20mg/ml)Cyclosporin A (100mg/ml)Cytarabine (Cytosine)(100 mg/ml) | Halyard Purple Nitrile*Powder-Free Exam Gloves,Tested for Use withChemotherapy Drugs,Fentanyl Citrate,Simulated Gastric Acid andFentanyl in SimulatedGastric Acid are disposabledevices intended formedical purposes that isworn on the examiner'shand to preventcontamination betweenpatient and examiner.The followingchemotherapy drugs andconcentration had NObreakthrough detected upto 240 minutes:Azacitidine (25 mg/ml)Bendamustine HCl (5mg/ml)Bleomycin Sulfate (15mg/ml)Bortezomib (1 mg/ml)Busulfan (6 mg/ml)Capecitabine (26 mg/ml)Carboplatin (10 mg/ml)Carlzomib (2 mg/ml)Cetuximab (2 mg/ml)Chloroquine (50 mg/ml)Cisplatin (1 mg/ml)Cladribine (1 mg/ml)Cyclophosphamide (20mg/ml)Cyclosporin A (100 mg/ml)Cytarabine (Cytosine) (100mg/ml)Cytovene (Ganciclovir) (10mg/ml)Dacarbazine (DTIC) (10mg/ml)Dactinomycin (0.5 mg/ml)Daunorubicin HCl (5mg/ml)Decitabine (5 mg/ml)Docetaxel (10 mg/ml)Doxorubicin HCl (2 mg/ml)Epirubicin HCL (Ellence) (2 | Halyard LavenderNitrile, LowDermatitis Potential,Powder-Free ExamGloves Tested for Usewith ChemotherapyDrugs, FentanylCitrate and SimulatedGastric AcidFluid/Fentanyl CitrateInjection Mix 50/50Solution aredisposable devicesintended for medicalpurposes that is wornon the examiner'shand to preventcontaminationbetween patient andexaminer. Thesegloves were testedfor use with thefollowingchemotherapy drugs,Fentanyl Citrate andSimulatedGastric AcidFluid/Fentanyl CitrateInjection Mix 50/50Solution as per ASTM -D6978-05:The followingchemotherapy drugsand concentration hadNO breakthroughdetected up to 240minutes:Azacitidine (25 mg/ml)Bendamustine HCI (5mg/ml)Bleomycin Sulfate (15mg/ml)Bortezomib (1 mg/ml)Busulfan (6 mg/ml)Capecitabine (26mg/ml)Carboplatin (10 mg/ml)Carlzomib (2 mg/ml)Cetuximab (2 mg/ml)Chloroquine (50 | SimilarAdding LowDermatitisPotentialclaim tosubjectdevice ascompared toreferencepredicate |
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Image /page/8/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.
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Image /page/9/Picture/0 description: The image shows the logo for Owens & Minor. The logo consists of the letters "OM" in a bold, maroon color on the left side of the image. To the right of the letters is the company name "Owens & Minor" in a light gray color. The logo is simple and professional, and the colors are complementary.
| Cytovene (Ganciclovir) (10 mg/ml)Dacarbazine (DTIC) (10 mg/ml)Dactinomycin (0.5 mg/ml)Daunorubicin HCl (5 mg/ml)Decitabine (5 mg/ml)Docetaxel (10 mg/ml)Doxorubicin HCl (2 mg/ml)Epirubicin HCl (Ellence) (2 mg/ml)Etoposide (Toposar) (20 mg/ml)Fludarabine (25 mg/ml)5-Fluorouracil (50 mg/ml)Fulvestrant (50 mg/ml)Gemcitabine (38 mg/ml)Idarubicin (1 mg/ml)Ifosfamide (50 mg/ml)Irinotecan HCl (20 mg/ml)Leuprolide Acetate Salt (5 mg/ml)Mechlorethamine HCl (1 mg/ml)Melphalan (5 mg/ml)Methotrexate (25 mg/ml)Mitomycin C (0.5 mg/ml)Mitoxantrone (2 mg/ml)Oxaliplatin (5 mg/ml)Paclitaxel (6 mg/ml)Pemetrexed (25 mg/ml)Raltitrexed (0.5 mg/ml)Retrovir (10 mg/ml)Rituximab (10 mg/ml)Temsirolimus (25 mg/ml)Topotecan HCl (1 mg/ml)Triclosan (2 mg/ml)Trisenox (1 mg/ml)Vinblastine Sulfate (1 mg/ml)Vincristine (1 mg/ml)Vinorelbine (10 mg/ml)Zoledronic Acid (0.8 mg/ml) | Etoposide (Toposar) (20 mg/ml)Fludarabine (25 mg/ml)5-Fluorouracil (50 mg/ml)Fulvestrant (50 mg/ml)Gemcitabine (38 mg/ml)Idarubicin (1 mg/ml)Ifosfamide (50 mg/ml)Irinotecan HCl (20 mg/ml)Leuprolide Acetate Salt (5 mg/ml)Mechlorethamine HCl (1 mg/ml)Melphalan (5 mg/ml)Methotrexate (25 mg/ml)Mitomycin C (0.5 mg/ml)Mitoxantrone (2 mg/ml)Oxaliplatin (5 mg/ml)Paclitaxel (6 mg/ml)Pemetrexed (25 mg/ml)Raltitrexed (0.5 mg/ml)Retrovir (10 mg/ml)Rituximab (10 mg/ml)Temsirolimus (25 mg/ml)Topotecan HCl (1 mg/ml)Triclosan (2 mg/ml)Trisenox (1 mg/ml)Vinblastine Sulfate (1 mg/ml)Vincristine (1 mg/ml)Vinorelbine (10 mg/ml)Zoledronic Acid (0.8 mg/ml)The followingchemotherapy drugs andconcentration showedbreakthrough detected inless than 90 minutes:Carmustine (3.3 mg/ml)No breakthrough up to55.3 minutes.Thiotepa (10 mg/ml) Nobreakthrough up to 78.8minutes.Warning- Not for use withCarmustine and ThioTEPA | Cisplatin (1 mg/ml)Cladribine (1 mg/ml)Cyclophosphamide (20 mg/ml)Cyclosporin A (100 mg/ml)Cytarabine (Cytosine) (100 mg/ml)Cytovene (Ganciclovir) (10 mg/ml)Dacarbazine (DTIC) (10 mg/ml)Dactinomycin (0.5 mg/ml)Daunorubicin HCl (5 mg/ml)Decitabine (5 mg/ml)Docetaxel (10 mg/ml)Doxorubicin HCl (2 mg/ml)Epirubicin HCl (Ellence) (2 mg/ml)Etoposide (Toposar) (20 mg/ml)Fludarabine (25 mg/ml)5-Fluorouracil (50 mg/ml)Fulvestrant (50 mg/ml)Gemcitabine (38 mg/ml)Idarubicin (1 mg/ml)Ifosfamide (50 mg/ml)Irinotecan HCl (20 mg/ml)Leuprolide Acetate Salt (5 mg/ml)Mechlorethamine HCl (1 mg/ml)Melphalan (5 mg/ml)Methotrexate (25 mg/ml)Mitomycin C (0.5 mg/ml)Mitoxantrone (2 mg/ml)Oxaliptin (5 mg/ml)Paclitaxel (6 mg/ml)Pemetrexed (25 mg/ml) |
|---|---|---|
| Vinorelbine (10 mg/ml)Zoledronic Acid (0.8 mg/ml) | No breakthrough was detected up to 240 minutes for Fentanyl Citrate Injection (100 mcg/2 ml) and Simulated Gastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 Solution | Raltitrexed (0.5 mg/ml)Retrovir (10 mg/ml)Rituximab (10 mg/ml)Temsirolimus (25 mg/ml)Topotecan HCI (1 mg/ml)Triclosan (2 mg/ml)Trisenox (1 mg/ml)Vinblastine Sulfate (1 mg/ml)Vincristine (1 mg/ml)Vinorelbine (10 mg/ml)Zoledronic Acid (0.8 mg/ml) |
| The following chemotherapy drugs and concentration showed breakthrough detected in less than 90 minutes:Carmustine (3.3 mg/ml) No breakthrough up to 55.3 minutes.Thiotepa (10 mg/ml) No breakthrough up to 78.8 minutes.Warning- Not for use with Carmustine and ThioTEPAThe 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 chemotherapy drugs and concentration showed breakthrough detected in less than 60 minutes:Carmustine (3.3 mg/ml) No breakthrough up to 0.3 minutes.Thiotepa (10 mg/ml) No breakthrough up to 30.9 minutes.The following hazardous drugs (opioids) and concentration had NO breakthrough detected up to 240 minutes:Fentanyl Citrate Injection (100 mcg/2 ml) and Simulated Gastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 SolutionWarning: Not for Use With: Carmustine, ThioTEPA |
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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 maroon-colored emblem on the left and the company name in gray on the right. The emblem features the letters "OM" in a stylized design with horizontal lines running through the "O". The company name "Owens & Minor" is written in a serif font, with "Owens" stacked above "& Minor".
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Image /page/11/Picture/0 description: The image is a 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 is the company name "Owens & Minor" in a light gray color. The ampersand symbol is also in light gray.
| TechnologicalCharacteristics | Colored, 9.5 inch,chlorinated, nitrile,powder-free, texturedfingertip,ambidextrous, non-sterile patientexamination glove | Colored, 9.5 inch,chlorinated, nitrile,powder-free, texturedfingertips, ambidextrous,non-sterile patientexamination glove | Colored, 9.5 inch,chlorinated, nitrile,powder-free, texturedfingertip,ambidextrous, non-sterile patientexamination glove | Same |
|---|---|---|---|---|
| Sizes of gloves | XS, S, M, L, XL, XXL | XS, S, M, L, XL | XS, S, M, L, XL | SimilarAdding XXLsize tosubjectdevice |
| Color | Purple | Purple | Lavender | Similar |
| Texture | Textured fingertips | Textured fingertips | Textured fingertips | Same |
| Sterility | Non-Sterile | Non-Sterile | Non-Sterile | Same |
| Biocompatibility | Based on ISO 10993,Part 11 BiologicalEvaluation of MedicalDevices – Test forsystemic toxicity, thetest article wasconsidered non- toxic.Meets the acceptancecriteria.Based on ISO 10993,Part 23- BiologicalEvaluation of MedicalDevices – Test forirritation, the testarticle was considerednon-irritant. Meets theacceptance criteria.Based on ISO 10993,Part 10 - BiologicalEvaluation of MedicalDevices – Test for skinsensitization, the testarticle was considered anon- sensitizer. Meetsthe acceptance criteria. | Based on ISO 10993, Part 11Biological Evaluation ofMedical devices - Test forsystemic toxicity, the testarticle was considerednon-toxic. Meets theacceptance criteria.Based on ISO 10993, Part10- Biological Evaluationof Medical Devices – Testfor irritation, the testarticle was considerednon- irritant. Meets theacceptance criteria.Based on ISO 10993, Part10 - Biological Evaluationof Medical Devices – Testfor skin sensitization, thetest article wasconsidered non-sensitizer.Meets the acceptancecriteria. | Based on ISO 10993,Part 11 BiologicalEvaluation of MedicalDevices - Test forsystemic toxicity, thetest article wasconsidered non-toxic.Meets the acceptancecriteria.Based on ISO 10993,Part 10- BiologicalEvaluation of MedicalDevices – Test forirritation, the testarticle was considerednon-irritant. Meets theacceptance criteria.Based on ISO 10993,Part 10 - BiologicalEvaluation of MedicalDevices – Test for skinsensitization, the testarticle was considereda non- sensitizer.Meets the acceptancecriteria. | Same |
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Image /page/12/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 the "O". The company name, "Owens & Minor," is written in a serif font, with "&" connecting the two names.
| Performance Data for Chemotherapy Drugs | ||||
|---|---|---|---|---|
| Standard | Subject Device(K241909) | Predicate Device(K213929) | Reference Device(K213937) | Remarks |
| ASTM D6978-05Standard Practice forAssessment ofResistance of MedicalGloves to Permeationby ChemotherapyDrugs | The followingchemotherapy drugsand concentration hadNO breakthroughdetected up to 240minutes:Azacitidine (25 mg/ml)Bendamustine HCl (5mg/ml)Bleomycin Sulfate (15mg/ml)Bortezomib (1 mg/ml)Busulfan (6 mg/ml)Capecitabine (26mg/ml)Carboplatin (10 mg/ml)Carlzomib (2 mg/ml)Cetuximab (2 mg/ml)Chloroquine (50mg/ml)Cisplatin (1 mg/ml)Cladribine (1 mg/ml)Cyclophosphamide (20mg/ml)Cyclosporin A (100mg/ml)Cytarabine (Cytosine)(100 mg/ml)Cytovene (Ganciclovir)(10 mg/ml)Dacarbazine (DTIC) (10mg/ml)Dactinomycin (0.5mg/ml)Daunorubicin HCl (5mg/ml)Decitabine (5 mg/ml)Docetaxel (10 mg/ml)Doxorubicin HCl (2mg/ml)Epirubicin HCl (Ellence)(2 mg/ml)Etoposide (Toposar)(20 mg/ml) | The followingchemotherapy drugs andconcentration had NObreakthrough detected upto 240 minutes:Azacitidine (25 mg/ml)Bendamustine HCl (5mg/ml)Bleomycin Sulfate (15mg/ml)Bortezomib (1 mg/ml)Busulfan (6 mg/ml)Capecitabine (26 mg/ml)Carboplatin (10 mg/ml)Carlzomib (2 mg/ml)Cetuximab (2 mg/ml)Chloroquine (50 mg/ml)Cisplatin (1 mg/ml)Cladribine (1 mg/ml)Cyclophosphamide (20mg/ml)Cyclosporin A (100 mg/ml)Cytarabine (Cytosine) (100mg/ml)Cytovene (Ganciclovir) (10mg/ml)Dacarbazine (DTIC) (10mg/ml)Dactinomycin (0.5 mg/ml)Daunorubicin HCl (5mg/ml)Decitabine (5 mg/ml)Docetaxel (10 mg/ml)Doxorubicin HCl (2 mg/ml)Epirubicin HCl (Ellence) (2mg/ml)Etoposide (Toposar) (20mg/ml)Fludarabine (25 mg/ml)5-Fluorouracil (50 mg/ml)Fulvestrant (50 mg/ml)Gemcitabine (38 mg/ml)Idarubicin (1 mg/ml)Ifosfamide (50 mg/ml) | The followingchemotherapy drugsand concentration hadNO breakthroughdetected up to 240minutes:Azacitidine (25 mg/ml)Bendamustine HCl (5mg/ml)Bleomycin Sulfate (15mg/ml)Bortezomib (1 mg/ml)Busulfan (6 mg/ml)Capecitabine (26mg/ml)Carboplatin (10 mg/ml)Carlzomib (2 mg/ml)Cetuximab (2 mg/ml)Chloroquine (50mg/ml)Cisplatin (1 mg/ml)Cladribine (1 mg/ml)Cyclophosphamide (20mg/ml)Cyclosporin A (100mg/ml)Cytarabine (Cytosine)(100 mg/ml)Cytovene (Ganciclovir)(10 mg/ml)Dacarbazine (DTIC) (10mg/ml)Dactinomycin (0.5mg/ml)Daunorubicin HCl (5mg/ml)Decitabine (5 mg/ml)Docetaxel (10 mg/ml)Doxorubicin HCl (2mg/ml)Epirubicin HCl (Ellence)(2 mg/ml)Etoposide (Toposar)(20 mg/ml) | Similar |
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Image /page/13/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 the letters "OM" with horizontal lines running through them. The company name, "Owens & Minor," is written in a serif font, with the "&" symbol connecting the two names.
| Fludarabine (25 mg/ml) | Irinotecan HCl (20 mg/ml) | Fludarabine (25 mg/ml) |
|---|---|---|
| 5-Fluorouracil (50mg/ml) | Leuprolide Acetate Salt (5mg/ml) | 5-Fluorouracil (50mg/ml) |
| Fulvestrant (50 mg/ml) | Mechlorethamine HCl (1mg/ml) | Fulvestrant (50 mg/ml) |
| Gemcitabine (38mg/ml) | Melphalan (5 mg/ml) | Gemcitabine (38mg/ml) |
| Idarubicin (1 mg/ml) | Methotrexate (25 mg/ml) | Idarubicin (1 mg/ml) |
| Ifosfamide (50 mg/ml) | Mitomycin C (0.5 mg/ml) | Ifosfamide (50 mg/ml) |
| Irinotecan HCl (20mg/ml) | Mitoxantrone (2 mg/ml) | Irinotecan HCl (20mg/ml) |
| Leuprolide Acetate Salt(5 mg/ml) | Oxaliplatin (5 mg/ml) | Leuprolide Acetate Salt(5 mg/ml) |
| Mechlorethamine HCl(1 mg/ml) | Paclitaxel (6 mg/ml) | Mechlorethamine HCl(1 mg/ml) |
| Melphalan (5 mg/ml) | Pemetrexed (25 mg/ml) | Melphalan (5 mg/ml) |
| Methotrexate (25mg/ml) | Raltitrexed (0.5 mg/ml) | Methotrexate (25mg/ml) |
| Mitomycin C (0.5mg/ml) | Retrovir (10 mg/ml) | Mitomycin C (0.5mg/ml) |
| Mitoxantrone (2mg/ml) | Rituximab (10 mg/ml) | Mitoxantrone (2mg/ml) |
| Oxaliplatin (5 mg/ml) | Temsirolimus (25 mg/ml) | Oxaliplatin (5 mg/ml) |
| Paclitaxel (6 mg/ml) | Topotecan HCl (1 mg/ml) | Pemetrexed (25mg/ml) |
| Pemetrexed (25mg/ml) | Triclosan (2 mg/ml) | Paclitaxel (6 mg/ml) |
| Raltitrexed (0.5 mg/ml) | Trisenox (1 mg/ml) | Raltitrexed (0.5 mg/ml) |
| Retrovir (10 mg/ml) | Vinblastine Sulfate (1mg/ml) | Retrovir (10 mg/ml) |
| Rituximab (10 mg/ml) | Vincristine (1 mg/ml) | Rituximab (10 mg/ml) |
| Temsirolimus (25mg/ml) | Vinorelbine (10 mg/ml) | Temsirolimus (25mg/ml) |
| Topotecan HCl (1mg/ml) | Zoledronic Acid (0.8mg/ml) | Topotecan HCl (1mg/ml) |
| Triclosan (2 mg/ml) | The followingchemotherapy drugs andconcentration showedbreakthrough detected inless than 90 minutes: | Triclosan (2 mg/ml) |
| Trisenox (1 mg/ml) | Carmustine (3.3 mg/ml)No breakthrough up to | Trisenox (1 mg/ml) |
| Vinblastine Sulfate (1mg/ml) | 55.3 minutes.Thiotepa (10 mg/ml) Nobreakthrough up to 78.8minutes. | Vinblastine Sulfate (1mg/ml) |
| Vincristine (1 mg/ml) | Warning- Not for use withCarmustine and ThioTEPA | Vincristine (1 mg/ml) |
| Vinorelbine (10 mg/ml) | Vinorelbine (10 mg/ml) | |
| Zoledronic Acid (0.8mg/ml) | The following | Zoledronic Acid (0.8mg/ml) |
| The following | chemotherapy drugs | |
| chemotherapy drugs | and concentration | |
| and concentration | showed | |
| showed breakthrough | breakthrough detected | |
| detected in less than | in less than | |
| 90 minutes: | 60 minutes: | |
| Carmustine (3.3mg/ml) No | Carmustine (3.3mg/ml) No | |
| breakthrough up to | breakthrough up to 0.3 |
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Image /page/14/Picture/0 description: The image shows the logo for Owens & Minor. The logo consists of the letters "OM" in a dark red color on the left side of the image. To the right of the letters is the name "Owens & Minor" in a light gray color. The letters "OM" have horizontal lines going through them.
| Performance Data for Hazardous Drugs (opioids) | |||||
|---|---|---|---|---|---|
| 55.3 minutes.Thiotepa (10 mg/ml)No breakthrough up to78.8 minutes.Warning- Not for usewith Carmustine andThioTEPA | minutes.Thiotepa (10 mg/ml)Nobreakthrough up to30.9 minutes.Warning: Not for UseWith:Carmustine, Thiotepa | ||||
| ASTM D6978-05Standard Practice forAssessment ofResistance of MedicalGloves to Permeationby ChemotherapyDrugs | The followinghazardous drugs(opioids) andconcentration hadNO breakthroughdetected up to 240minutes:Fentanyl CitrateInjection (100 mcg/2ml)Simulated GastricAcid Fluid/FentanylCitrate Injection Mix50/50 Solution | No breakthrough wasdetected up to 240minutes for FentanylCitrate Injection (100mcg/2 ml) and SimulatedGastric AcidFluid/Fentanyl CitrateInjection Mix 50/50Solution | The followinghazardous drugs(opioids) andconcentration had NObreakthrough detectedup to 240minutes:No breakthrough wasdetected up to 240minutes for FentanylCitrateInjection (100 mcg/2ml) and SimulatedGastric AcidFluid/Fentanyl CitrateInjection Mix 50/50Solution | Same |
| Performance Data | ||||
|---|---|---|---|---|
| ASTM D5151-06Standard Test Methodfor Detection of Holesin Medical Gloves | Testing of the subjectdevice shows it meetsthe 2.5% AQLrequirement in thestandards forleakage. The devicemeets theacceptance criteria ofthe standard. | Testing of the predicatedevice shows it meets the2.5% AQL requirement inthe standards for leakage.The device meets theacceptance criteria of thestandard. | Testing of thereference deviceshows it meets the2.5% AQL requirementin the standards forleakage. The devicemeets the acceptancecriteria of thestandard. | Same |
| ASTM D6124-06Standard TestMethod for ResidualPowder on MedicalGloves | Residual powder onthe subject device isan average of 0.4mg/glove within thepowder-free limit of <2 mg maximumpowder per glove andmeets theacceptance criteria | Residual powder on thepredicate device is anaverage of 0.4 mg/glovewithin the powder-freelimit of < 2 mg maximumpowder per glove andmeets the acceptancecriteria for powder-free. | Residual powder onthe reference device isan average of 0.4mg/glove within thepowder-free limit of <2 mg maximumpowder per glove andmeets the acceptancecriteria for powder- | Same |
| for powder-free. | free. | |||
| ASTM D6319-10StandardSpecification forNitrile ExaminationGloves for MedicalApplications | The physicaldimensions of thesubject device arewithin the limits ofthe standard and thephysical properties ofthe subject devicemet therequirements fortensile strengthbefore and afteraging. The subjectdevice also met therequirement forelongation beforeand after aging. | The physical dimensionsof the predicate deviceare within the limits ofthe standard and thephysical properties of thepredicate device met therequirements for tensilestrength before and afteraging. The predicatedevice also met therequirement forelongation before andafter aging. | The physicaldimensions of thereference device arewithin the limits of thestandard and thephysical properties ofthe reference devicemet the requirementsfor tensile strengthbefore and after aging.The reference devicealso met therequirement forelongation before andafter aging. | Same |
| Clinical test | A 204 subject studywas completed toevaluate whether thelevel of residualchemical additives inthe subject deviceinduced Type IVallergic contactsensitization byrepetitiveapplications to theskin of normalhealthy humanvolunteers using theJordan-Kingmodification of theDraize test asrecommended by theFDA. Under theconditions of thestudy, the subjectdevice wasnonirritating andshowed no clinicalevidence of residualchemical additivesthat may induce TypeIV allergy in humansubjects. | Not previously tested | A 204 subject studywas completed toevaluate whether thelevel of residualchemical additives inthe reference deviceinduced Type IVallergic contactsensitization byrepetitive applicationsto the skin of normalhealthy humanvolunteers using theJordan-Kingmodification of theDraize test asrecommended by theFDA. Under theconditions of thestudy, the referencedevice wasnonirritating andshowed no clinicalevidence of residualchemical additives thatmay induce Type IVallergy in humansubjects. | Different |
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Image /page/15/Picture/0 description: The image shows the logo for Owens & Minor. The logo consists of the letters "OM" in a bold, maroon font on the left side of the image. To the right of the letters is the company name "Owens & Minor" in a light gray font.
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Image /page/16/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 is the company name "Owens & Minor" in a light gray color. The logo is simple and modern, and the colors are professional and trustworthy.
SUMMARY OF NON-CLINICAL TESTING
| Brief description ofnon-clinical tests: | Test | Standard | Acceptance Criteria | Results |
|---|---|---|---|---|
| Dimensions | ASTM D 6319 | Length≥230 mmPalm Width SizeX-Small: 60 – 80 mmSmall: 70 – 90 mmMed: 85–105 mmLarge: 100 - 120 mmX-Large: 110-130 mmXX-Large: 120-140 mmFinger thickness≥0.05 mmPalm thickness≥0.05 mmCuff thickness≥0.05 mm | Meetsrequirements | |
| Physical Properties | ASTM D 6319 | AQL 4.0Before AgingTensile Strength: ≥14 MPaUltimate elongation:≥500%After AgingTensile Strength: ≥14 MPaUltimate elongation:≥400% | Meetsrequirements | |
| Freedom fromPinholes | ASTM D 6319ASTM D 5151 | AQL 2.5%No leakage | Meetsrequirements | |
| Powder Free | ASTM D 6124ASTM D 6319 | ≤ 2 mg / glove | Meetsrequirements | |
| Test for irritation | ISO 10993, Part 23 | Grade 1 | Under theconditions of thestudy, the deviceis not an irritant. | |
| Test for acutesystemic toxicity | ISO 10993, Part 11 | No animals treatedwith test extractsexhibit greaterreaction than controlanimals. | Under theconditions ofthe study, noevidence ofacute systemictoxicity. | |
| Test for skinsensitization | ISO 10993, Part 10 | Grade < 1.0 | Under theconditions of thestudy, the device isnot a sensitizer. | |
| Standard PracticeforAssessment ofResistance ofMedicalGloves toPermeationby ChemotherapyDrugs | ASTM D6978-05 | No breakthroughfor up to 240 minutes | No signs ofbreakthrough for thesubject device for 53chemotherapy drugs,Fentanyl CitrateInjection (100mcg/2ml) andSimulated GastricAcid Fluid/FentanylCitrate Injection Mix50/50Solution.Carmustine3.3mg/mlminimumbreakthroughdetection time is55.3 minutesThiotepa 10mg/mlminimumbreakthroughdetection time is78.8 minutes. |
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Image /page/17/Picture/0 description: The image shows the logo for Owens & Minor. The logo consists of the letters "OM" in a dark red color on the left side of the image. To the right of the letters is the name "Owens & Minor" in a light gray color.
SUMMARY OF CLINICAL TESTING
| Test | Description | Results |
|---|---|---|
| Modified DRAIZE-95Test toEvaluate LowDermatitisPotential of MedicalGloves | A 204 subject study was completed to evaluatewhether the level of residual chemical additives inthe subject device (K241909) induced Type IVallergic contact sensitization by repetitiveapplications to the skin of normal healthy humanvolunteers using the Jordan-King modification ofthe Draize test as recommended by the FDA. | Under the conditions ofthe study, the subjectdevice was nonirritatingand showed no clinicalevidence of residualchemical additives thatmay induce Type IV allergyin human subjects. |
| Conclusion: | The conclusions drawn from the nonclinical and clinical tests demonstrate that thesubject device Halyard Purple Nitrile* Powder-Free Exam Gloves, Low DermatitisPotential, tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acidclaims, is as safe, as effective, and perform as well as or better than the legallymarketed predicate device cleared under K213929. |
|---|---|
| ------------- | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
§ 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.