# K243172: Halyard Purple Nitrile* Powder-Free Exam Gloves, Sterile Pairs; Halyard Purple Nitrile* Powder-Free Exam Gloves, Sterile Singles

- Pathway: 510(k) (Abbreviated)
- Applicant: O&M Halyard, Inc.
- Decided: Jun 18, 2025 after 261 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 K992062 (1999). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102032: Kimberly-Clark Purple Nitrile Xtra* Sterile Powder-Free Exam Glove (Chemotherapy Glove) - 12 Sterile Pairs, Kimberly-Clark Corp. (2010) Summary page 6.

## Indications for use
The Halyard Purple Nitrile* Powder-Free Exam Gloves, Sterile Pairs or Sterile Singles, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid are disposable devices intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. The following chemotherapy drugs and concentration had NO breakthrough detected up to 240 minutes: Azacitidine (25 mg/ml) Bendamustine HCI (5 mg/ml) Bleomycin Sulfate (15 mg/ml) Bortezomib (1 mg/ml) Busulfan (6 mg/ml) Capecitabine (26 mg/ml) Carboplatin (10 mg/ml) Carfilzomib (2 mg/ml) Cetuximab (2 mg/ml) Cisplatin (1 mg/ml) Cladribine (1 mg/ml) Cyclophosphamide (20 mg/ml) Cytarabine HCI (100 mg/ml) Dacarbazine (10 mg/ml) Dactinomycin (0.5 mg/ml) Daunorubicin HCI (5 mg/ml) Decitabine (5 mg/ml) Docetaxel (10 mg/ml) Doxorubicin HCI (2 mg/ml) Epirubicin HCI (2 mg/ml) Etoposide (20 mg/ml) Fludarabine Phosphate (25 mg/ml) Fluorouracil (50 mg/ml) Fulvestrant (50 mg/ml) Gemcitabine HCI (38 mg/ml) Idarubicin HCI (1 mg/ml) Ifosfamide (50 mg/ml) Irinotecan HCI (20 mg/ml) Leuprolide Acetate (5 mg/ml) Mechlorethamine HCI (1 mg/ml) Melphalan HCI (5 mg/ml) Methotrexate (25 mg/ml) Mitomycin C (0.5 mg/ml) Mitoxantrone HCI (2 mg/ml) Oxaliplatin (5 mg/ml) Paclitaxel (6 mg/ml) Pemetrexed (25 mg/ml) Raltitrexed (0.5 mg/ml) Rituximab (10 mg/ml) Temsirolimus (25 mg/ml) Topotecan HCI (1 mg/ml) Trisenox (Arsenic Trioxide) (1 mg/ml) Vinblastine Sulfate (1 mg/ml) Vincristine (1 mg/ml) Vinorelbine Tartrate (10 mg/ml) The following chemotherapy drugs and concentration showed breakthrough detected in less than 100 minutes: Carmustine (3.3 mg/ml) No breakthrough up to 44.5 minutes. Thiotepa (10 mg/ml) No breakthrough up to 99.1 minutes. Warning- Not for use with Carmustine and ThioTEPA The following hazardous drugs (opioids) and concentration had NO breakthrough detected up to 240 minutes: Fentanyl Citrate Injection (100 mcg/2 ml) Simulated Gastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 Solution The following hazardous drugs and concentration had NO breakthrough detected up to 240 minutes: Chloroquine (50 mg/ml) Cyclosporin A (100 mg/ml) Cytovene (10 mg/ml) Retrovir (10 mg/ml) Triclosan (2 mg/ml) Zoledronic Acid (0.8 mg/ml)

Source page: https://510kreport.com/device/K243172
Methodology: https://510kreport.com/methodology