(175 days)
No
The 510(k) summary describes a physical medical device (exam gloves) and its performance testing against various chemicals. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML.
No
The device is an exam glove intended to prevent contamination, not to treat or cure a disease or condition.
No
This device is described as an exam glove intended to prevent contamination between patient and examiner. Its purpose is protective, not to identify or diagnose a disease or condition.
No
The device is a physical product (gloves) and not software. The description focuses on material properties and performance testing of the physical gloves.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as a "disposable device intended for medical purposes that are worn on the examiner's hand to prevent contamination between patient and examiner." This describes a barrier device for personal protection and infection control.
- Function: The device functions as a physical barrier to prevent the transfer of substances (including chemotherapy drugs and bodily fluids) between the wearer and the patient.
- IVD Definition: An In Vitro Diagnostic device is defined as a medical device that is used to perform tests on samples taken from the human body (such as blood, urine, or tissue) to diagnose diseases or other conditions. This device does not perform any such tests.
- Testing: While the gloves are tested for their resistance to chemotherapy drugs, this testing is to demonstrate their protective barrier properties, not to diagnose or provide information about a patient's condition.
Therefore, the Halyard Pink Underguard Zero Nitrile Sterile Powder-Free Exam Gloves Tested with Chemotherapy Drugs are classified as a medical device, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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 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.
Product codes (comma separated list FDA assigned to the subject device)
LZA, LZC, ODO
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance Data for Chemotherapy Drugs:
Standard: ASTM D6978-05 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs
Subject Device Results:
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 Injection, (100mcg /2mL). No breakthrough up to 240 minutes
Predicate Device K183132 Results:
Arsenic Trioxide (1 mg/ml) No breakthrough up to 240 minutes
Azacitidine (Vidaza) (25 mg/ml) No breakthrough up to 240 minutes
Bendamustine (5 mg/ml) No breakthrough up to 240 minutes
Bortezomib (Velcade) (1 mg/ml) No breakthrough up to 240 minutes
Bleomycin sulfate (15 mg/ml) No breakthrough up to 240 minutes
Busulfan (6 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 54.7 minutes
Cetuximab (Erbitux) (2 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
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
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
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
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
Paraplatin (10 mg/ml) No breakthrough up to 240 minutes
Pemetrexed (25 mg/ml) No breakthrough up to 240 minutes
Pertuzumab (30 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
Trastuzumab (21 mg/ml) No breakthrough up to 240 minutes
ThioTEPA (10 mg/ml) No breakthrough up to 134.7 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
Vincrinstine Sulfate (1 mg/ml) No breakthrough up to 240 minutes
Vinblastine (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
Standard: ASTM D 6978 for Fentanyl Citrate
Subject Device Results: Fentanyl Citrate Injection, (100mcg /2mL). No breakthrough up to 240 minutes.
Predicate Device Results: No tested (Different)
Standard: ASTM D5151-06 Standard Test Method for Detection of Holes in Medical Gloves
Subject Device Results: Testing of the subject device shows it meets the 2.5% AQL requirement in the standards for leakage. The device meets the acceptance criteria of the standard.
Predicate Device Results: Testing of the subject device shows it meets the 2.5% AQL requirement in the standards for leakage. The device meets the acceptance criteria of the standard.
Standard: ASTM D6124-06 Standard Test Method for Residual Powder on Medical Gloves
Subject Device Results: Residual powder on the subject device is an average of 0.4 mg/glove within the powder-free limit of
§ 880.6250 Non-powdered patient examination glove.
(a)
Identification. A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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)
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510(k) Summary
| Date Summary
| was Prepared | September 19, 2020 |
|---|---|
| 510(k) Submitter | O & M Halyard, Inc. |
| 5405 Windward Parkway | |
| Alpharetta, GA 30004 | |
| Primary Contact for | |
| this 510(k) Submission | Steven Dowdley, RAC |
| Tel: 678-451-8062 | |
| Email: steven.dowdley@hyh.com | |
| Device Trade Name | Halyard Pink Underguard Zero Nitrile Sterile Powder-Free Exam Gloves Tested with |
| Chemotherapy Drugs | |
| Device Common Name | Medical Exam Gloves |
| Device Product Code | |
| and Classification Name | LZC |
| Class I, 21 CFR §880.6250 Patient Examination Glove | |
| LZC Class I, 21 CFR §880.6250 Patient Examination Glove, Specialty | |
| OQD Class I, 21 CFR §880.6250 Fentanyl and other opioid protection glove | |
| Predicate Device | Halyard Pink Underguard Zero Nitrile Powder-Free Exam Glove Tested for |
| Use with Chemotherapy Drugs cleared under K183132 | |
| Subject Device Description | 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 device follows consensus standards: | |
| • ASTM D5151-06 Standard Test Method for Detection of Holes in Medical | |
| Gloves | |
| • ASTM D6319-10 Standard Specification for Nitrile Examination Gloves | |
| for Medical Applications | |
| • ASTM D6124-06 Standard Test Method for Residual Powder on Medical | |
| Gloves | |
| • ASTM D6978-05 Standard Practice for Assessment of Resistance of | |
| Medical Gloves to Permeation by Chemotherapy Drugs | |
| • ISO 10993-11:2017, Biological evaluation of medical devices - 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 the | |
| Halyard Pink Underguard Zero, | |
| Sterile Powder-Free Exam Glove | |
| Tested with Chemotherapy | The Halyard Pink Underguard Zero Nitrile Sterile Powder-Free Exam Gloves |
| Tested with Chemotherapy Drugs are disposable devices intended for medical | |
| purposes that is worn on the examiner's hand to prevent contamination between | |
| patient and examiner. These gloves were tested for use with 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 showed | |
| breakthrough detected in less than 60 minutes: Carmustine (BCNU): 59 | |
| minutes. |
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 Zero | ||
| Nitrile Sterile Powder-Free | |||
| Exam Gloves Tested with | |||
| Chemotherapy Drugs | Halyard Pink Underguard Nitrile | ||
| Powder-Free Exam Glove Tested for | |||
| Use with Chemotherapy Drugs | Similar | ||
| Intended Use | Halyard Pink Underguard Nitrile | ||
| Sterile Powder-Free Exam Gloves | |||
| Tested with Chemotherapy Drugs | |||
| are disposable device intended for | |||
| medical purposes that is worn on | |||
| the examiner's hand to prevent | |||
| contamination between patient | |||
| and examiner. These gloves were | |||
| tested for use with chemotherapy | |||
| drugs listed on the label. | The Halyard Pink Underguard | ||
| Nitrile Powder-Free Exam Glove | |||
| Tested for Use with Chemotherapy | |||
| Drugs is a disposable device | |||
| intended for medical purposes that | |||
| is worn on the examiner's hand to | |||
| prevent contamination between | |||
| patient and examiner. | |||
| These gloves were tested for use | |||
| with chemotherapy drugs listed on | |||
| the label. | Same | ||
| Technological | |||
| Characteristics | The glove is a colored, nitrile, | ||
| powder-free, textured fingertip, | |||
| ambidextrous, patient examination | |||
| glove. | The glove is a colored, nitrile, | ||
| powder-free, textured fingertip, | |||
| ambidextrous, patient examination | |||
| glove. | 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 Biological | ||
| evaluation of Medical devices - | |||
| Test for Systemic Injection, the | |||
| test article was considered non- | |||
| toxic. Meets the acceptance | |||
| criteria. | Based ISO 10993 Biological | ||
| evaluation of Medical devices - | |||
| Test for Systemic Injection, the test | |||
| article was considered non-toxic. | |||
| Meets the acceptance criteria. | Similar | ||
| Based on ISO 10993- Biological | |||
| evaluation of Medical Devices - | |||
| Test for Skin Irritation, the device | |||
| extracts were not found to cause a | |||
| systemic response in the animal | |||
| model. Meets the acceptance | |||
| criteria. | Based on ISO 10993- Biological | ||
| evaluation of Medical Devices - | |||
| Test for Skin Irritation, the device | |||
| extracts were not found to cause a | |||
| systemic response in the animal | |||
| model. Meets the acceptance | |||
| criteria. | |||
| Based on ISO 10993- Biological | |||
| evaluation of Medical Device | |||
| Dermal Sensitization- | |||
| ISO Kligman Maximization Test - | |||
| NaCl and CSO extracts. The test | |||
| article were classified as a non- | |||
| sensitizer. Based on the criteria of | |||
| the protocol, the test article meets | |||
| the requirements of the ISO | |||
| 10993-10 guidelines. | Based on ISO 10993- Biological | ||
| evaluation of Medical Device | |||
| Dermal Sensitization- | |||
| ISO Kligman Maximization Test - | |||
| NaCl and CSO extracts. The test | |||
| article were classified as a non- | |||
| sensitizer. Based on the criteria of | |||
| the protocol, the test article meets | |||
| the requirements of the ISO 10993- | |||
| 10 guidelines. |
| Performance Data for Chemotherapy Drugs | |||
|---|---|---|---|
| Standard | Results | ||
| Subject Device | |||
| (sterile) | Results | ||
| Predicate Device K183132 | Remarks | ||
| ASTM D6978-05 | |||
| Standard Practice | |||
| for Assessment of | |||
| Resistance of | |||
| Medical Gloves to | |||
| Permeation by | |||
| Chemotherapy | |||
| Drugs | 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 | Arsenic Trioxide (1 mg/ml) No | ||
| breakthrough up to 240 minutes | |||
| Azacitidine (Vidaza) (25 mg/ml) No | |||
| breakthrough up to 240 minutes | |||
| Bendamustine (5 mg/ml) No breakthrough | |||
| up to 240 minutes | |||
| Bortezomib (Velcade) (1 mg/ml) No | |||
| breakthrough up to 240 minutes | |||
| Bleomycin sulfate (15 mg/ml) No | |||
| breakthrough up to 240 minutes | |||
| Busulfan (6 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 54.7 minutes | Similar |
8
| Cetuximab (Erbitux) (2 mg/ml) No
breakthrough up to 240 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 | |
| Cisplatin (1 mg/ml) No breakthrough
up to 240 minutes | Cladribine (1.0 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 | |
| Cyclophosphamide (20 mg/ml) No
breakthrough up to 240 minutes | Cytarabine HCL (100 mg/ml) No
breakthrough up to 240 minutes | |
| Cyclosporine A (100 mg/ml) No
breakthrough up to 240 minutes | Cytovene (10 mg/ml) No breakthrough up
to 240 minutes | |
| Cytarabine HCL (100 mg/ml) No
breakthrough up to 240 minutes | Dacarbazine (10 mg/ml) No breakthrough
up to 240 minutes | |
| Cytovene (10 mg/ml) No breakthrough
up to 240 minutes | Daunorubicin HCL (5 mg/ml) No
breakthrough up to 240 minutes | |
| Dacarbazine (10 mg/ml) No
breakthrough up to 240 minutes | Decitabine (5 mg/ml) No breakthrough up
to 240 minutes | |
| Dactinomycin (0.5 mg/ml) No
breakthrough up to 240 minutes | Docetaxel (10 mg/ml) No breakthrough up
to 240 minutes | |
| Daunorubicin HCL (5 mg/ml) No
breakthrough up to 240 minutes | Doxorubicin HCL (2 mg/ml) No
breakthrough up to 240 minutes | |
| Decitabine (5 mg/ml) No breakthrough
up to 240 minutes | Epirubicin (Ellence) (2 mg/ml) No
breakthrough up to 240 minutes | |
| Docetaxel (10 mg/ml) No breakthrough
up to 240 minutes | Etoposide (20 mg/ml) No breakthrough up
to 240 minutes | |
| Doxorubicin HCL (2 mg/ml) No
breakthrough up to 240 minutes | Fludarabine (25 mg/ml) No breakthrough
up to 240 minutes | |
| Epirubicin (Ellence) (2 mg/ml) No
breakthrough up to 240 minutes | Fluorouracil (50 mg/ml) No breakthrough
up to 240 minutes | |
| Etoposide (20 mg/ml) No breakthrough
up to 240 minutes | Fulvestrant (50 mg/ml) No breakthrough
up to 240 minutes | |
| Fludarabine (25 mg/ml) No
breakthrough up to 240 minutes | Gemcitabine (38 mg/ml) No breakthrough
up to 240 minutes | |
| 5-Fluorouracil (50 mg/ml) No
breakthrough up to 240 minutes | Idarubicin (1 mg/ml) No breakthrough up
to 240 minutes | |
| Fulvestrant (50 mg/ml) No
breakthrough up to 240 minutes | Ifosfamide (50 mg/ml) No breakthrough up
to 240 minutes | |
| Gemcitabine (38 mg/ml) No
breakthrough up to 240 minutes | Irinotecan (20 mg/ml) No breakthrough up
to 240 minutes | |
| Idarubicin (1 mg/ml) No breakthrough
up to 240 minutes | Mechlorethamine HCL (1 mg/ml) No
breakthrough up to 240 minutes | |
| Ifosfamide (50 mg/ml) No
breakthrough up to 240 minutes | Melphalan (5 mg/ml) No breakthrough up
to 240 minutes | |
| Irinotecan (20 mg/ml) No breakthrough
up to 240 minutes | Methotrexate (25 mg/ml) No breakthrough
up to 240 minutes | |
| Leuprolide acetate salt (5mg/ml) No
breakthrough up to 240 minutes | Mitomycin-C (0.5 mg/ml) No breakthrough
up to 240 minutes | |
| Mechlorethamine HCL (1 mg/ml) No
breakthrough up to 240 minutes | Mitoxantrone (2 mg/ml) No breakthrough
up to 240 minutes | |
| Melphalan (5 mg/ml) No breakthrough
up to 240 minutes | Oxaliplatin (2 mg/ml) No breakthrough up
to 240 minutes | |
| Methotrexate (25 mg/ml) No
breakthrough up to 240 minutes | Paclitaxel (6 mg/ml) No breakthrough up
to 240 minutes | |
| Mitomycin-C (0.5 mg/ml) No
breakthrough up to 240 minutes | Paraplatin (10 mg/ml) No breakthrough up
to 240 minutes | |
| Mitoxantrone (2 mg/ml) No
breakthrough up to 240 minutes | Pemetrexed (25 mg/ml) No breakthrough
up to 240 minutes | |
| Oxaliplatin (2 mg/ml) No breakthrough
up to 240 minutes | Pertuzumab (30 mg/ml) No breakthrough
up to 240 minutes | |
| Paclitaxel (6 mg/ml) No breakthrough
up to 240 minutes | Raltitrexed (0.5 mg/ml) No breakthrough
up to 240 minutes | |
| Pemetrexed (25 mg/ml) No
breakthrough up to 240 minutes | Retrovir (10 mg/ml) No breakthrough up to
240 minutes | |
| Raltitrexed (0.5 mg/ml) No
breakthrough up to 240 minutes | Rituximab (10 mg/ml) No breakthrough up
to 240 minutes | |
| Retrovir (10 mg/ml) No breakthrough
up to 240 minutes | Temsirolimus (25 mg/ml) No breakthrough
up to 240 minutes | |
| Rituximab (10 mg/ml) No breakthrough
up to 240 minutes | Trastuzumab (21 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 134.7 minutes | |
| ThioTEPA (10 mg/ml) No breakthrough
up to 240 minutes | Topotecan HCL (1 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 | |
| Triclosan (1 mg/ml) No breakthrough
up to 240 minutes | Trisenox (0.1 mg/ml) No breakthrough up
to 240 minutes | |
| Trisenox (0.1 mg/ml) No breakthrough
up to 240 minutes | Vincrinstine Sulfate (1 mg/ml) No
breakthrough up to 240 minutes | |
| Vinblastine (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 | |
| Vinorelbine (10 mg/ml) No
breakthrough up to 240 minutes | Zoledronic Acid (0.8 mg/ml) No
breakthrough up to 240 minutes | |
| Zoledronic Acid (0.8 mg/ml) No
breakthrough up to 240 minutes | | |
9
10
| Performance Data for Chemotherapy Drugs | |||
|---|---|---|---|
| Standard | Results | ||
| Subject Device | |||
| (sterile) | Results | ||
| Predicate Device K183132 | Remarks | ||
| ASTM D 6978 | Fentanyl Citrate Injection, (100mcg | ||
| /2mL). No breakthrough up to 240 | |||
| minutes | No tested | Different |
| ASTM D5151-06
Standard Test
Method for Detection
of Holes in Medical
Gloves | Testing of the subject device
shows it meets the 2.5% AQL
requirement in the standards for
leakage. The device meets the
acceptance criteria of the
standard. | Testing of the subject device shows it
meets the 2.5% AQL requirement in
the standards for leakage. The device
meets the acceptance criteria of the
standard. | Same |
|-------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------|
| ASTM D6124-06
Standard Test
Method for Residual
Powder on Medical
Gloves | Residual powder on the subject
device is an average of 0.4
mg/glove within the powder-free
limit of