# K183132: Halyard Pink Underguard Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs

- Pathway: 510(k) (Abbreviated)
- Applicant: O&M Halyard, Inc.
- Decided: Feb 5, 2019 after 84 days
- Product code: LZC (Medical Glove, Specialty)
- 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: 2 generations back to K042805 (2004). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081089: Kimberly-Clark Sterling Nitrile & Nitrile-Xtra Powder-Free Exam Gloves with Chemotherapy Drug Use Claim, Kimberly-Clark Corp. (2008) Summary page 5.

## Most influential descendants
- K200843: Halyard Pink Underguard Zero, Sterile Powder-Free Exam Gloves Tested with Chemotherapy Drugs (2020), 0 descendants of its own

## Indications for use
The Halyard Pink Underguard Nitrile Powder-Free Exam Glove 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 the following chemotherapy drugs: • 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 • Car¬filzomib (2 mg/ml) No breakthrough up to 240 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 • Topotecan HCL (1 mg/ml) No breakthrough up to 240 minutes • Triclosan (2 mg/ml) No breakthrough up to 240 minutes • Trisonex (1.0 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 CAUTION: The following chemotherapy drugs and concentration showed breakthrough detected in less than 240 minutes: • Carmustine (3.3 mg/ml) No breakthrough up to 54.7 minutes • ThioTEPA (10 mg/ml) No breakthrough up to 128.5 minutes

Source page: https://510kreport.com/device/K183132
Methodology: https://510kreport.com/methodology