# K243604: Halyard Purple Nitrile-XTRA* Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Fentanyl Citrate in Simulated Gastric Acid

- Pathway: 510(k) (Abbreviated)
- Applicant: O&M Halyard, Inc.
- Decided: Aug 18, 2025 after 270 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 6.

## Indications for use
Halyard Purple Nitrile-XTRA* Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Fentanyl Citrate 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: Arsenic Trioxide (1 mg/ml) Bendamustine, (5 mg/ml) Blenoxane (15 mg/ml) Bleomycin (15 mg/ml) Bortezomib (1 mg/ml) Busulfan (6 mg/ml) Carboplatln (10 mg/ml) Carfilzomib (2 mg/ml) Cetuximab (2 mg/ml) Cisplatin (1 mg/ml) Cyclophosphamide (Cytoxan) (20 mg/ml) Cytarabine (100 mg/ml) Dacarbazine (DTIC) {10 mg/ml) Daunorubicin {5 mg/ml) Decitabine (5 mg/ml) Docetaxel (10 mg/ml) Doxorubicin HCL (2 mg/ml) Ellence (2 mg/ml) Erbitux (2 mg/ml) Eribilin Mesylate (0.5 mg/ml) Etoposide (Toposar) (20 mg/ml) Fludarabine (25 mg/ml) Fulvestrant (50 mg/ml) Gemcitabine (Gemzar) (38 mg/ml) ldarubicin (1 mg/ml) Ifosfamide (IFEX) (50 mg/ml) Irinotecan (20 mg/ml) Mechlorethamine HCL (1 mg/ml) Melphalan (5 mg/ml) Methotrexate (25 mg/ml) Mitomycin C (0.5 mg/ml) Mitoxantrone (2 mg/ml) Oxaliplatin (2 mg/ml) Paclitaxel (Taxol) (6 mg/ml) Paraplatin (10 mg/ml) Pemetrexed Disodium (25 mg/ml) Pertuzumab (30 mg/ml) Raltitrexed (0.5 mg/ml) Rituximab (Rituxan) (10 mg/ml) Temsirolimus (25 mg/ml) Thiotepa (10 mg/ml) Topotecan HCL (1 mg/ml) Trastuzumab (21 mg/ml) Trisenox (1 mg/ml) Velcade (1 mg/ml) Vinblastine (1 mg/ml) Vinorelbine (10 mg/ml) Carmustine (3.3 mg/ml) permeation occurred at 60.0 minutes. The following hazardous drugs (opioids) and concentration had NO breakthrough detected up to 240 minutes: Fentanyl Citrate Injection (100 mcg/2 ml) Gastric Acid Fluid/Fentanyl Citrate Injection Mix (50/50 Solution) Caution: Testing showed a minimum breakthrough time of 60.0 minutes with Carmustine. The following hazardous drugs and concentration had NO breakthrough detected up to 240 minutes: Cytovene (10 mg/ml) Retrovir (10 mg/ml) Triclosan (2 mg/ml) Zoledronic Acid (0.8 mg/ml)

Source page: https://510kreport.com/device/K243604
Methodology: https://510kreport.com/methodology