K Number
K200843Device Name
Halyard Pink Underguard Zero, Sterile Powder-Free Exam Gloves Tested with Chemotherapy DrugsManufacturer
Date Cleared
2020-09-22
(175 days)
Regulation Number
880.6250Type
AbbreviatedPanel
HOReference & Predicate Devices
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended 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 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.
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.
AI/ML Overview
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 |
§ 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.