# K182096: Halyard Purple Nitrile Max Powder-Free Exam Gloves for Use with Chemotherapy Drugs

- Pathway: 510(k) (Abbreviated)
- Applicant: Owens & Minor Halyard, Inc.
- Decided: Nov 2, 2018 after 91 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: 5 generations back to K051347 (2005). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160709: HALYARD* PURPLE NITRILE – XTRA* Powder-Free Exam Gloves, Halyard Health (2016) Summary page 5.

## Indications for use
The Halyard Purple Nitrile Max Powder-Free Nitrile 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 • Carlzomib (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 • ThioTEPA (10 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 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 Carmustine (3.3 mg/ml) permeation occurred at 128.5 minutes

Source page: https://510kreport.com/device/K182096
Methodology: https://510kreport.com/methodology