(175 days)
Halyard Pink Underguard Zero Nitrile Sterile Powder-Free Exam Gloves Tested with Chemotherapy Drugs are disposable device 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 as per ASTM-D6978-05: Azacitidine (Vidaza) (25 mg/ml) No breakthrough up to 240 minutes Bendamustine (5 mg/ml) No breakthrough up to 240 minutes Bleomycin sulfate (15 mg/ml) No breakthrough up to 240 minutes Bortezomib (6 mg/ml) No breakthrough up to 240 minutes Busulfan (6 mg/ml) No breakthrough up to 240 minutes Capecitabine (26 mg/ml) No breakthrough up to 240 minutes Carboplatin (10 mg/ml) No breakthrough up to 240 minutes Carfilzomib (2 mg/ml) No breakthrough up to 240 minutes Carmustine (3.3 mg/ml) permeation occurred at 59.0 minutes Cetuximab (Erbitux) (2 mg/ml) No breakthrough up to 240 minutes Chloroquine (50 mg/ml) No breakthrough up to 240 minutes Cisplatin (1 mg/ml) No breakthrough up to 240 minutes Cladribine (1.0 mg/ml) No breakthrough up to 240 minutes Cyclophosphamide (20 mg/ml) No breakthrough up to 240 minutes Cyclosporine A (100 mg/ml) No breakthrough up to 240 minutes Cytarabine 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 Dactinomycin (0.5 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 (10 mg/ml) No breakthrough up to 240 minutes Doxorubicin HCL (2 mg/ml) No breakthrough up to 240 minutes Epirubicin (Ellence) (2 mg/ml) No breakthrough up to 240 minutes Etoposide (20 mg/ml) No breakthrough up to 240 minutes Fludarabine (25 mg/ml) No breakthrough up to 240 minutes 5-Fluorouracil (50 mg/ml) Nobreakthrough up 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 Irinotecan (20 mg/ml) No breakthrough up to 240 minutes Leuprolide acetate salt (5mg/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 Mitoxantrone (2 mg/ml) No breakthrough up to 240 minutes Oxaliplatin (2 mg/ml) No breakthrough up to 240 minutes Paclitaxel (6 mg/ml) No breakthrough up to 240 minutes Pemetrexed (25 mg/ml) No breakthrough up to 240 minutes Raltitrexed (0.5 mg/ml) No breakthrough up to 240 minutes Retrovir (10 mg/ml) No breakthrough up to 240 mimutes Rituximab (10 mg/ml) No breakthrough up to 240 minutes Temsirolimus (25 mg/ml) No breakthrough up to 240 minutes ThioTEPA (10 mg/ml) No breakthrough up to 240 minutes Topotecan HCL (1 mg/ml) No breakthrough up to 240 minutes Triclosan (1 mg/ml) No breakthrough up to 240 minutes Trisenox (0.1 mg/ml) No breakthrough up to 240 minutes Vinblastine (1 mg/ml) No breakthrough up to 240 minutes Vincrinstine Sulfate (1 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 Injection, (100mcg /2mL). No breakthrough up to 240 minutes CAUTION: The following chemotherapy drugs and concentration showed breakthrough detected in less than 60 minutes. Carmustine (BCNU): 59 minutes.
The Halyard Pink Underguard Zero Nitrile Sterile Powder-Free Exam Gloves Tested with Chemotherapy Drugs are disposable, pink-colored, chlorinated, nitrile, powder-free, textured fingertip, ambidextrous, sterile patient examination gloves.
The document describes the acceptance criteria and performance of the "Halyard Pink Underguard Zero Nitrile Sterile Powder-Free Exam Gloves Tested with Chemotherapy Drugs" to demonstrate substantial equivalence to a predicate device.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria & Standard | Reported Device Performance |
|---|---|
| ASTM D6978-05: Assessment of Resistance to Permeation by Chemotherapy Drugs (Breakthrough Time) | |
| - Azacitidine (Vidaza) (25 mg/ml) | No breakthrough up to 240 minutes |
| - Bendamustine (5 mg/ml) | No breakthrough up to 240 minutes |
| - Bleomycin sulfate (15 mg/ml) | No breakthrough up to 240 minutes |
| - Bortezomib (6 mg/ml) | No breakthrough up to 240 minutes |
| - Busulfan (6 mg/ml) | No breakthrough up to 240 minutes |
| - Capecitabine (26 mg/ml) | No breakthrough up to 240 minutes |
| - Carboplatin (10 mg/ml) | No breakthrough up to 240 minutes |
| - Carfilzomib (2 mg/ml) | No breakthrough up to 240 minutes |
| - Carmustine (3.3 mg/ml) | Permeation occurred at 59.0 minutes (Caution: Breakthrough detected in less than 60 minutes) |
| - Cetuximab (Erbitux) (2 mg/ml) | No breakthrough up to 240 minutes |
| - Chloroquine (50 mg/ml) | No breakthrough up to 240 minutes |
| - Cisplatin (1 mg/ml) | No breakthrough up to 240 minutes |
| - Cladribine (1.0 mg/ml) | No breakthrough up to 240 minutes |
| - Cyclophosphamide (20 mg/ml) | No breakthrough up to 240 minutes |
| - Cyclosporine A (100 mg/ml) | No breakthrough up to 240 minutes |
| - Cytarabine 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 |
| - Dactinomycin (0.5 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 (10 mg/ml) | No breakthrough up to 240 minutes |
| - Doxorubicin HCL (2 mg/ml) | No breakthrough up to 240 minutes |
| - Epirubicin (Ellence) (2 mg/ml) | No breakthrough up to 240 minutes |
| - Etoposide (20 mg/ml) | No breakthrough up to 240 minutes |
| - Fludarabine (25 mg/ml) | No breakthrough up to 240 minutes ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| - 5-Fluorouracil (50 mg/ml) | No breakthrough up 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 ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| - Irinotecan (20 mg/ml) | No breakthrough up to 240 minutes ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| - Leuprolide acetate salt (5mg/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 ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| - Mitoxantrone (2 mg/ml) | No breakthrough up to 240 minutes ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| - Oxaliplatin (2 mg/ml) | No breakthrough up to 240 minutes ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| - Paclitaxel (6 mg/ml) | No breakthrough up to 240 minutes ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| - Pemetrexed (25 mg/ml) | No breakthrough up to 240 minutes ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| - Raltitrexed (0.5 mg/ml) | No breakthrough up to 240 minutes ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| - Retrovir (10 mg/ml) | No breakthrough up to 240 minutes ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| - Rituximab (10 mg/ml) | No breakthrough up to 240 minutes ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| - Temsirolimus (25 mg/ml) | No breakthrough up to 240 minutes ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| - ThioTEPA (10 mg/ml) | No breakthrough up to 240 minutes ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| - Topotecan HCL (1 mg/ml) | No breakthrough up to 240 minutes ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| - Triclosan (1 mg/ml) | No breakthrough up to 240 minutes No breakthrough up to 240 minutes |
| - Trisenox (0.1 mg/ml) | No breakthrough up to 240 minutes ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| - Vinblastine (1 mg/ml) | No breakthrough up to 240 minutes -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| - Vincristine Sulfate (1 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 Injection (100mcg/2mL) | No breakthrough up to 240 minutes |
| ASTM D5151-06: Detection of Holes in Medical Gloves | Meets the 2.5% AQL requirement in the standards for leakage. Meets the acceptance criteria. |
| ASTM D6124-06: Residual Powder on Medical Gloves | Average of 0.4 mg/glove, within the powder-free limit of < 2 mg maximum powder per glove. Meets the acceptance criteria for powder-free. |
| ASTM D6319-10: Nitrile Examination Gloves for Medical Applications (Physical Dimensions & Properties) | Physical dimensions are within the limits of the standard. Physical properties (tensile strength before and after aging, elongation before and after aging) met the requirements. |
| ISO 10993 Biological evaluation of medical devices (Systemic Toxicity) | Test article considered non-toxic. Meets the acceptance criteria. |
| ISO 10993-10: Biological evaluation of medical devices (Skin Irritation) | Device extracts not found to cause a systemic response in the animal model. Meets the acceptance criteria. |
| ISO 10993-10: Biological evaluation of medical devices (Dermal Sensitization) | Test article classified as a non-sensitizer based on ISO Kligman Maximization Test - NaCl and CSO extracts. Meets the requirements of the ISO 10993-10 guidelines. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the sample sizes used for each specific test (e.g., number of gloves tested for chemotherapy permeation, number of gloves for hole detection). However, it indicates compliance with recognized standards (ASTM, ISO), which typically specify sample size requirements for testing.
The data provenance is from non-clinical tests conducted to evaluate the device's performance against established standards. The country of origin and whether the data is retrospective or prospective are not specified in this document, as these are lab tests, not human studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is a submission for a patient examination glove and involves non-clinical performance and biocompatibility testing. Therefore, there are no "experts" in the sense of clinical reviewers establishing ground truth from medical images or patient data. The "ground truth" is established by the specified test methods and their acceptance criteria within the cited ASTM and ISO standards. The tests are performed by qualified laboratory personnel following these protocols.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. As this is non-clinical performance testing of a physical device against specified standards, adjudication methods like 2+1 or 3+1 (typically used for clinical or imaging studies) are not relevant. The results are objectively measured and compared to the predefined criteria in the standards.
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 is a submission for a patient examination glove, not an AI-powered diagnostic device. No MRMC study was conducted or is relevant to this type of device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a physical medical device (exam glove), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the device's performance is defined by the acceptance criteria specified within the referenced consensus standards:
- ASTM D6978-05 for chemotherapy drug permeation (no breakthrough for a specified time).
- ASTM D5151-06 for detection of holes (2.5% AQL requirement).
- ASTM D6124-06 for residual powder (< 2 mg maximum powder per glove).
- ASTM D6319-10 for physical dimensions and properties (tensile strength, elongation).
- ISO 10993-11, 10993-10 for biocompatibility (non-toxic, non-irritant, non-sensitizer).
These standards provide objective, measurable criteria for the device's performance.
8. The sample size for the training set
Not applicable. This is a physical medical device, not a machine learning model. There is no concept of a "training set."
9. How the ground truth for the training set was established
Not applicable for the reason stated above.
{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.
September 22, 2020
೦&M Halyard, Inc. Steven Dowdley Associate Director of Regulatory Affairs 9120 Lockwood Blvd Mechanicsville, Virginia 23116
Re: K200843
Trade/Device Name: Halyard Pink Underguard Zero Nitrile Sterile Powder-Free Exam Glove Tested with Chemotherapy Drugs Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA, LZC, ODO Dated: August 17, 2020 Received: August 21, 2020
Dear Steven Dowdley:
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 (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 located 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.
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
{1}------------------------------------------------
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 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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).
Sincerely,
For: CAPT Elizabeth Claverie, M.S. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K200843
Device Name
Halyard Pink Underguard Zero Nitrile Sterile Powder-Free Exam Gloves Tested with Chemotherapy Drues
Indications for Use (Describe)
Halyard Pink Underguard Zero Nitrile Sterile Powder-Free Exam Gloves Tested with Chemotherapy Drugs are disposable device 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 as per ASTM-D6978-05: Azacitidine (Vidaza) (25 mg/ml) No breakthrough up to 240 minutes Bendamustine (5 mg/ml) No breakthrough up to 240 minutes Bleomycin sulfate (15 mg/ml) No breakthrough up to 240 minutes Bortezomib (6 mg/ml) No breakthrough up to 240 minutes Busulfan (6 mg/ml) No breakthrough up to 240 minutes Capecitabine (26 mg/ml) No breakthrough up to 240 minutes Carboplatin (10 mg/ml) No breakthrough up to 240 minutes Carfilzomib (2 mg/ml) No breakthrough up to 240 minutes Carmustine (3.3 mg/ml) permeation occurred at 59.0 minutes Cetuximab (Erbitux) (2 mg/ml) No breakthrough up to 240 minutes Chloroquine (50 mg/ml) No breakthrough up to 240 minutes Cisplatin (1 mg/ml) No breakthrough up to 240 minutes Cladribine (1.0 mg/ml) No breakthrough up to 240 minutes Cyclophosphamide (20 mg/ml) No breakthrough up to 240 minutes Cyclosporine A (100 mg/ml) No breakthrough up to 240 minutes Cytarabine 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 Dactinomycin (0.5 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 (10 mg/ml) No breakthrough up to 240 minutes Doxorubicin HCL (2 mg/ml) No breakthrough up to 240 minutes Epirubicin (Ellence) (2 mg/ml) No breakthrough up to 240 minutes Etoposide (20 mg/ml) No breakthrough up to 240 minutes Fludarabine (25 mg/ml) No breakthrough up to 240 minutes 5-Fluorouracil (50 mg/ml) Nobreakthrough up 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 Irinotecan (20 mg/ml) No breakthrough up to 240 minutes Leuprolide acetate salt (5mg/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
List of chemotherapy drugs continues on next page
Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2020
{3}------------------------------------------------
K200843: Continuation of the list of chemotherapy drugs from previous page. These gloves were tested for use with the following chemotherapy drugs and Fentanyl Citrate as per ASTM D6978-05:
Mitoxantrone (2 mg/ml) No breakthrough up to 240 minutes Oxaliplatin (2 mg/ml) No breakthrough up to 240 minutes Paclitaxel (6 mg/ml) No breakthrough up to 240 minutes Pemetrexed (25 mg/ml) No breakthrough up to 240 minutes Raltitrexed (0.5 mg/ml) No breakthrough up to 240 minutes Retrovir (10 mg/ml) No breakthrough up to 240 mimutes Rituximab (10 mg/ml) No breakthrough up to 240 minutes Temsirolimus (25 mg/ml) No breakthrough up to 240 minutes ThioTEPA (10 mg/ml) No breakthrough up to 240 minutes Topotecan HCL (1 mg/ml) No breakthrough up to 240 minutes Triclosan (1 mg/ml) No breakthrough up to 240 minutes Trisenox (0.1 mg/ml) No breakthrough up to 240 minutes Vinblastine (1 mg/ml) No breakthrough up to 240 minutes Vincrinstine Sulfate (1 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
Fentany I Citrate Injection, (100mcg /2mL). No breakthrough up to 240 minutes
CAUTION: The following chemotherapy drugs and concentration showed breakthrough detected in less than 60 minutes. Carmustine (BCNU): 59 minutes.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
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."
{4}------------------------------------------------
510(k) Summary
| Date Summarywas Prepared | September 19, 2020 |
|---|---|
| 510(k) Submitter | O & M Halyard, Inc.5405 Windward ParkwayAlpharetta, GA 30004 |
| Primary Contact forthis 510(k) Submission | Steven Dowdley, RACTel: 678-451-8062Email: steven.dowdley@hyh.com |
| Device Trade Name | Halyard Pink Underguard Zero Nitrile Sterile Powder-Free Exam Gloves Tested withChemotherapy Drugs |
| Device Common Name | Medical Exam Gloves |
| Device Product Codeand Classification Name | LZCClass I, 21 CFR §880.6250 Patient Examination GloveLZC Class I, 21 CFR §880.6250 Patient Examination Glove, SpecialtyOQD Class I, 21 CFR §880.6250 Fentanyl and other opioid protection glove |
| Predicate Device | Halyard Pink Underguard Zero Nitrile Powder-Free Exam Glove Tested forUse with Chemotherapy Drugs cleared under K183132 |
| Subject Device Description | The Halyard Pink Underguard Zero Nitrile Sterile Powder-Free ExamGloves Tested with Chemotherapy Drugs are disposable, pink-colored,chlorinated, nitrile, powder-free, textured fingertip, ambidextrous, sterilepatient examination gloves.The device follows consensus standards:• ASTM D5151-06 Standard Test Method for Detection of Holes in MedicalGloves• ASTM D6319-10 Standard Specification for Nitrile Examination Glovesfor Medical Applications• ASTM D6124-06 Standard Test Method for Residual Powder on MedicalGloves• ASTM D6978-05 Standard Practice for Assessment of Resistance ofMedical Gloves to Permeation by Chemotherapy Drugs |
| • ISO 10993-11:2017, Biological evaluation of medical devices - Part11:Tests for Systemic Toxicity• ISO 10993-10: 2010: Biological evaluation of medical devices - Part 10:Tests for Irritation and Skin Sensitization | |
| Indications for Use for theHalyard Pink Underguard Zero,Sterile Powder-Free Exam GloveTested with Chemotherapy | The Halyard Pink Underguard Zero Nitrile Sterile Powder-Free Exam GlovesTested with Chemotherapy Drugs are disposable devices intended for medicalpurposes that is worn on the examiner's hand to prevent contamination betweenpatient and examiner. These gloves were tested for use with the following |
| Drugs | chemotherapy drugs and Fentanyl Citrate as per ASTM -D6978-05.: |
| Azacitidine (Vidaza) (25 mg/ml) No breakthrough up to 240 minutes | |
| Bendamustine (5 mg/ml) No breakthrough up to 240 minutes | |
| Bleomycin sulfate (15 mg/ml) No breakthrough up to 240 minutes | |
| Bortezomib (6 mg/ml) No breakthrough up to 240 minutes | |
| Busulfan (6 mg/ml) No breakthrough up to 240 minutes | |
| Capecitabine (26 mg/ml) No breakthrough up to 240 minutes | |
| Carboplatin (10 mg/ml) No breakthrough up to 240 minutes | |
| Carfilzomib (2 mg/ml) No breakthrough up to 240 minutes | |
| Carmustine (3.3 mg/ml) permeation occurred at 59.0 minutes | |
| Cetuximab (Erbitux) (2 mg/ml) No breakthrough up to 240 minutes | |
| Chloroquine (50 mg/ml) No breakthrough up to 240 minutes | |
| Cisplatin (1 mg/ml) No breakthrough up to 240 minutes | |
| Cladribine (1.0 mg/ml) No breakthrough up to 240 minutes | |
| Cyclophosphamide (20 mg/ml) No breakthrough up to 240 minutes | |
| Cyclosporine A (100 mg/ml) No breakthrough up to 240 minutes | |
| Cytarabine 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 | |
| Dactinomycin (0.5 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 (10 mg/ml) No breakthrough up to 240 minutes | |
| Doxorubicin HCL (2 mg/ml) No breakthrough up to 240 minutes | |
| Epirubicin (Ellence) (2 mg/ml) No breakthrough up to 240 minutes | |
| Etoposide (20 mg/ml) No breakthrough up to 240 minutes | |
| Fludarabine (25 mg/ml) No breakthrough up to 240 minutes | |
| 5-Fluorouracil (50 mg/ml) No breakthrough up 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 | |
| Irinotecan (20 mg/ml) No breakthrough up to 240 minutes | |
| Leuprolide acetate salt (5mg/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 | |
| Mitoxantrone (2 mg/ml) No breakthrough up to 240 minutes | |
| Oxaliplatin (2 mg/ml) No breakthrough up to 240 minutes | |
| Paclitaxel (6 mg/ml) No breakthrough up to 240 minutes | |
| Pemetrexed (25 mg/ml) No breakthrough up to 240 minutes | |
| Raltitrexed (0.5 mg/ml) No breakthrough up to 240 minutes | |
| Retrovir (10 mg/ml) No breakthrough up to 240 minutes | |
| Rituximab (10 mg/ml) No breakthrough up to 240 minutes | |
| Temsirolimus (25 mg/ml) No breakthrough up to 240 minutes | |
| ThioTEPA (10 mg/ml) No breakthrough up to 240 minutes | |
| Topotecan HCL (1 mg/ml) No breakthrough up to 240 minutes | |
| Triclosan (1 mg/ml) No breakthrough up to 240 minutes | |
| Trisenox (0.1 mg/ml) No breakthrough up to 240 minutes | |
| Vinblastine (1 mg/ml) No breakthrough up to 240 minutes | |
| Vincrinstine Sulfate (1 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 breakthrough up to 240 minutes. | |
| CAUTION: The following chemotherapy drugs and concentration showedbreakthrough detected in less than 60 minutes: Carmustine (BCNU): 59minutes. |
{5}------------------------------------------------
{6}------------------------------------------------
| Summary of comparison of technological characteristics | The subject device and the predicate device are both sterile, powder-free nitrile exam gloves tested for resistance to permeation by chemotherapy drugs. |
|---|---|
| -------------------------------------------------------- | ---------------------------------------------------------------------------------------------------------------------------------------------------------- |
| Technological Characteristics Comparison Table | |||
|---|---|---|---|
| Subject Device | Predicate Device K183132 | Comparison | |
| FDA Product Code | LZA, LZC, QDO | LZA, LZC | Same |
| FDA Classification | Class I | Class I | Same |
| Regulation Number | 880.6250 | 880.6250 | Same |
| Common Name | Medical Exam Glove | Medical Exam Glove | Same |
| Device Trade Name | Halyard Pink Underguard ZeroNitrile Sterile Powder-FreeExam Gloves Tested withChemotherapy Drugs | Halyard Pink Underguard NitrilePowder-Free Exam Glove Tested forUse with Chemotherapy Drugs | Similar |
| Intended Use | Halyard Pink Underguard NitrileSterile Powder-Free Exam GlovesTested with Chemotherapy Drugsare disposable device intended formedical purposes that is worn onthe examiner's hand to preventcontamination between patientand examiner. These gloves weretested for use with chemotherapydrugs listed on the label. | The Halyard Pink UnderguardNitrile Powder-Free Exam GloveTested for Use with ChemotherapyDrugs is a disposable deviceintended for medical purposes thatis worn on the examiner's hand toprevent contamination betweenpatient and examiner.These gloves were tested for usewith chemotherapy drugs listed onthe label. | Same |
| TechnologicalCharacteristics | The glove is a colored, nitrile,powder-free, textured fingertip,ambidextrous, patient examinationglove. | The glove is a colored, nitrile,powder-free, textured fingertip,ambidextrous, patient examinationglove. | Same |
| Sizes of gloves | XS, S, M, L, XL(Sterile) | XS, S, M, L, XL | Different |
| Texture | Textured fingertips (Sterile) | Textured fingertips | Different |
{7}------------------------------------------------
| Sterility | Sterile. | Non Sterile | Different |
|---|---|---|---|
| Biocompatibility | Based ISO 10993 Biologicalevaluation of Medical devices -Test for Systemic Injection, thetest article was considered non-toxic. Meets the acceptancecriteria. | Based ISO 10993 Biologicalevaluation of Medical devices -Test for Systemic Injection, the testarticle was considered non-toxic.Meets the acceptance criteria. | Similar |
| Based on ISO 10993- Biologicalevaluation of Medical Devices -Test for Skin Irritation, the deviceextracts were not found to cause asystemic response in the animalmodel. Meets the acceptancecriteria. | Based on ISO 10993- Biologicalevaluation of Medical Devices -Test for Skin Irritation, the deviceextracts were not found to cause asystemic response in the animalmodel. Meets the acceptancecriteria. | ||
| Based on ISO 10993- Biologicalevaluation of Medical DeviceDermal Sensitization-ISO Kligman Maximization Test -NaCl and CSO extracts. The testarticle were classified as a non-sensitizer. Based on the criteria ofthe protocol, the test article meetsthe requirements of the ISO10993-10 guidelines. | Based on ISO 10993- Biologicalevaluation of Medical DeviceDermal Sensitization-ISO Kligman Maximization Test -NaCl and CSO extracts. The testarticle were classified as a non-sensitizer. Based on the criteria ofthe protocol, the test article meetsthe requirements of the ISO 10993-10 guidelines. |
| Performance Data for Chemotherapy Drugs | |||
|---|---|---|---|
| Standard | ResultsSubject Device(sterile) | ResultsPredicate Device K183132 | Remarks |
| ASTM D6978-05Standard Practicefor Assessment ofResistance ofMedical Gloves toPermeation byChemotherapyDrugs | Azacitidine (Vidaza) (25 mg/ml) Nobreakthrough up to 240 minutesBendamustine (5 mg/ml) Nobreakthrough up to 240 minutesBleomycin sulfate (15 mg/ml) Nobreakthrough up to 240 minutesBortezomib (6 mg/ml) No breakthroughup to 240 minutesBusulfan (6 mg/ml) No breakthroughup to 240 minutesCapecitabine (26 mg/ml) Nobreakthrough up to 240 minutesCarboplatin (10 mg/ml) Nobreakthrough up to 240 minutesCarfilzomib (2 mg/ml) No breakthroughup to 240 minutesCarmustine (3.3 mg/ml) permeationoccurred at 59.0 minutes | Arsenic Trioxide (1 mg/ml) Nobreakthrough up to 240 minutesAzacitidine (Vidaza) (25 mg/ml) Nobreakthrough up to 240 minutesBendamustine (5 mg/ml) No breakthroughup to 240 minutesBortezomib (Velcade) (1 mg/ml) Nobreakthrough up to 240 minutesBleomycin sulfate (15 mg/ml) Nobreakthrough up to 240 minutesBusulfan (6 mg/ml) No breakthrough up to240 minutesCarboplatin (10 mg/ml) No breakthroughup to 240 minutesCarfilzomib (2 mg/ml) No breakthrough upto 240 minutesCarmustine (3.3 mg/ml) permeationoccurred at 54.7 minutes | Similar |
{8}------------------------------------------------
| Cetuximab (Erbitux) (2 mg/ml) Nobreakthrough up to 240 minutes | Cetuximab (Erbitux) (2 mg/ml) Nobreakthrough up to 240 minutes | |
|---|---|---|
| Chloroquine (50 mg/ml) Nobreakthrough up to 240 minutes | Cisplatin (1 mg/ml) No breakthrough up to240 minutes | |
| Cisplatin (1 mg/ml) No breakthroughup to 240 minutes | Cladribine (1.0 mg/ml) No breakthroughup to 240 minutes | |
| Cladribine (1.0 mg/ml) Nobreakthrough up to 240 minutes | Cyclophosphamide (20 mg/ml) Nobreakthrough up to 240 minutes | |
| Cyclophosphamide (20 mg/ml) Nobreakthrough up to 240 minutes | Cytarabine HCL (100 mg/ml) Nobreakthrough up to 240 minutes | |
| Cyclosporine A (100 mg/ml) Nobreakthrough up to 240 minutes | Cytovene (10 mg/ml) No breakthrough upto 240 minutes | |
| Cytarabine HCL (100 mg/ml) Nobreakthrough up to 240 minutes | Dacarbazine (10 mg/ml) No breakthroughup to 240 minutes | |
| Cytovene (10 mg/ml) No breakthroughup to 240 minutes | Daunorubicin HCL (5 mg/ml) Nobreakthrough up to 240 minutes | |
| Dacarbazine (10 mg/ml) Nobreakthrough up to 240 minutes | Decitabine (5 mg/ml) No breakthrough upto 240 minutes | |
| Dactinomycin (0.5 mg/ml) Nobreakthrough up to 240 minutes | Docetaxel (10 mg/ml) No breakthrough upto 240 minutes | |
| Daunorubicin HCL (5 mg/ml) Nobreakthrough up to 240 minutes | Doxorubicin HCL (2 mg/ml) Nobreakthrough up to 240 minutes | |
| Decitabine (5 mg/ml) No breakthroughup to 240 minutes | Epirubicin (Ellence) (2 mg/ml) Nobreakthrough up to 240 minutes | |
| Docetaxel (10 mg/ml) No breakthroughup to 240 minutes | Etoposide (20 mg/ml) No breakthrough upto 240 minutes | |
| Doxorubicin HCL (2 mg/ml) Nobreakthrough up to 240 minutes | Fludarabine (25 mg/ml) No breakthroughup to 240 minutes | |
| Epirubicin (Ellence) (2 mg/ml) Nobreakthrough up to 240 minutes | Fluorouracil (50 mg/ml) No breakthroughup to 240 minutes | |
| Etoposide (20 mg/ml) No breakthroughup to 240 minutes | Fulvestrant (50 mg/ml) No breakthroughup to 240 minutes | |
| Fludarabine (25 mg/ml) Nobreakthrough up to 240 minutes | Gemcitabine (38 mg/ml) No breakthroughup to 240 minutes | |
| 5-Fluorouracil (50 mg/ml) Nobreakthrough up to 240 minutes | Idarubicin (1 mg/ml) No breakthrough upto 240 minutes | |
| Fulvestrant (50 mg/ml) Nobreakthrough up to 240 minutes | Ifosfamide (50 mg/ml) No breakthrough upto 240 minutes | |
| Gemcitabine (38 mg/ml) Nobreakthrough up to 240 minutes | Irinotecan (20 mg/ml) No breakthrough upto 240 minutes | |
| Idarubicin (1 mg/ml) No breakthroughup to 240 minutes | Mechlorethamine HCL (1 mg/ml) Nobreakthrough up to 240 minutes | |
| Ifosfamide (50 mg/ml) Nobreakthrough up to 240 minutes | Melphalan (5 mg/ml) No breakthrough upto 240 minutes | |
| Irinotecan (20 mg/ml) No breakthroughup to 240 minutes | Methotrexate (25 mg/ml) No breakthroughup to 240 minutes | |
| Leuprolide acetate salt (5mg/ml) Nobreakthrough up to 240 minutes | Mitomycin-C (0.5 mg/ml) No breakthroughup to 240 minutes | |
| Mechlorethamine HCL (1 mg/ml) Nobreakthrough up to 240 minutes | Mitoxantrone (2 mg/ml) No breakthroughup to 240 minutes | |
| Melphalan (5 mg/ml) No breakthroughup to 240 minutes | Oxaliplatin (2 mg/ml) No breakthrough upto 240 minutes | |
| Methotrexate (25 mg/ml) Nobreakthrough up to 240 minutes | Paclitaxel (6 mg/ml) No breakthrough upto 240 minutes | |
| Mitomycin-C (0.5 mg/ml) Nobreakthrough up to 240 minutes | Paraplatin (10 mg/ml) No breakthrough upto 240 minutes | |
| Mitoxantrone (2 mg/ml) Nobreakthrough up to 240 minutes | Pemetrexed (25 mg/ml) No breakthroughup to 240 minutes | |
| Oxaliplatin (2 mg/ml) No breakthroughup to 240 minutes | Pertuzumab (30 mg/ml) No breakthroughup to 240 minutes | |
| Paclitaxel (6 mg/ml) No breakthroughup to 240 minutes | Raltitrexed (0.5 mg/ml) No breakthroughup to 240 minutes | |
| Pemetrexed (25 mg/ml) Nobreakthrough up to 240 minutes | Retrovir (10 mg/ml) No breakthrough up to240 minutes | |
| Raltitrexed (0.5 mg/ml) Nobreakthrough up to 240 minutes | Rituximab (10 mg/ml) No breakthrough upto 240 minutes | |
| Retrovir (10 mg/ml) No breakthroughup to 240 minutes | Temsirolimus (25 mg/ml) No breakthroughup to 240 minutes | |
| Rituximab (10 mg/ml) No breakthroughup to 240 minutes | Trastuzumab (21 mg/ml) No breakthroughup to 240 minutes | |
| Temsirolimus (25 mg/ml) Nobreakthrough up to 240 minutes | ThioTEPA (10 mg/ml) No breakthrough upto 134.7 minutes | |
| ThioTEPA (10 mg/ml) No breakthroughup to 240 minutes | Topotecan HCL (1 mg/ml) Nobreakthrough up to 240 minutes | |
| Topotecan HCL (1 mg/ml) Nobreakthrough up to 240 minutes | Triclosan (1 mg/ml) No breakthrough up to240 minutes | |
| Triclosan (1 mg/ml) No breakthroughup to 240 minutes | Trisenox (0.1 mg/ml) No breakthrough upto 240 minutes | |
| Trisenox (0.1 mg/ml) No breakthroughup to 240 minutes | Vincrinstine Sulfate (1 mg/ml) Nobreakthrough up to 240 minutes | |
| Vinblastine (1 mg/ml) No breakthroughup to 240 minutes | Vinblastine (1 mg/ml) No breakthrough upto 240 minutes | |
| Vincrinstine Sulfate (1 mg/ml) Nobreakthrough up to 240 minutes | Vinorelbine (10 mg/ml) No breakthroughup to 240 minutes | |
| Vinorelbine (10 mg/ml) Nobreakthrough up to 240 minutes | Zoledronic Acid (0.8 mg/ml) Nobreakthrough up to 240 minutes | |
| Zoledronic Acid (0.8 mg/ml) Nobreakthrough up to 240 minutes |
{9}------------------------------------------------
{10}------------------------------------------------
| Performance Data for Chemotherapy Drugs | |||
|---|---|---|---|
| Standard | ResultsSubject Device(sterile) | ResultsPredicate Device K183132 | Remarks |
| ASTM D 6978 | Fentanyl Citrate Injection, (100mcg/2mL). No breakthrough up to 240minutes | No tested | Different |
| ASTM D5151-06Standard TestMethod for Detectionof Holes in MedicalGloves | Testing of the subject deviceshows it meets the 2.5% AQLrequirement in the standards forleakage. The device meets theacceptance criteria of thestandard. | Testing of the subject device shows itmeets the 2.5% AQL requirement inthe standards for leakage. The devicemeets the acceptance criteria of thestandard. | Same |
|---|---|---|---|
| ASTM D6124-06Standard TestMethod for ResidualPowder on MedicalGloves | Residual powder on the subjectdevice is an average of 0.4mg/glove within the powder-freelimit of < 2 mg maximum powderper glove and meets theacceptance criteria for powder-free. | Residual powder on the subjectdevice is an average of 0.4 mg/glovewithin the powder-free limit of < 2 mgmaximum powder per glove andmeets the acceptance criteria forpowder- free. | Same |
| ASTM D6319-10StandardSpecification forNitrile ExaminationGloves for MedicalApplications | The physical dimensions of thesubject device are within the limitsof the standard and the physicalproperties of the subject devicemet the requirements for tensilestrength before and after aging.The subject device also met therequirement for elongation beforeand after aging. | The physical dimensions of thesubject device are within the limits ofthe standard and the physicalproperties of the subject device metthe requirements for tensile strengthbefore and after aging. The subjectdevice also met the requirement forelongation before and after aging. | Same |
| ISO 10993Biologicalevaluation ofmedical devices | Meets acceptance criteria | Meets acceptance criteria | Same |
| Conclusion: | The conclusions drawn from the nonclinical tests demonstrate that the subject device,the Halyard Pink Underguard Zero Nitrile Sterile Powder-Free Exam Gloves Tested withChemotherapy Drugs are as safe, as effective, and performs as well as or better thanthe legally marketed predicate device. |
§ 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.