# K200843: Halyard Pink Underguard Zero, Sterile Powder-Free Exam Gloves Tested with Chemotherapy Drugs

- Pathway: 510(k) (Abbreviated)
- Applicant: O&M Halyard, Inc.
- Decided: Sep 22, 2020 after 175 days
- Product code: LZA (Polymer Patient Examination Glove)
- Device class: 1
- Regulation: 21 CFR 880.6250
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K042805 (2004). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183132: Halyard Pink Underguard Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs, O&M Halyard, Inc. (2019) Summary page 5.

## 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- 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.

Source page: https://510kreport.com/device/K200843
Methodology: https://510kreport.com/methodology