# K213937: Halyard Lavender Nitrile, Low Dermatitis Potential, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Simulated Gastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 Solution

- Pathway: 510(k) (Abbreviated)
- Applicant: O&M Halyard, Inc.
- Decided: Aug 16, 2022 after 243 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: 7 generations back to K042805 (2004). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202622: Halyard Lavender, Low Dermatitis Potential, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs and and Fentanyl Citrate, O&M Halyard, Inc. (2021) Summary page 5.

## Indications for use
Halyard Lavender Nitrile, Low Dermatitis Potential, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Simulated Gastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 Solution are disposable devices 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, Fentanyl Citrate and Simulated Gastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 Solution as per ASTM -D6978-05 : 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) Carlzomib (2 mg/ml) Cetuximab (2 mg/ml) Chloroquine (50 mg/ml) Cisplatin (1 mg/ml) Cladribine (1 mg/ml) Cyclophosphamide (20 mg/ml) Cyclosporin A (100 mg/ml) Cytarabine (Cytosine) (100 mg/ml) Cytovene (Ganciclovir) (10 mg/ml) Dacarbazine (DTIC) (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 (Ellence) (2 mg/ml) Etoposide (Toposar) (20 mg/ml) Fludarabine (25 mg/ml) 5-Fluorouracil (50 mg/ml) Fulvestrant (50 mg/ml) Gemcitabine (38 mg/ml) Idarubicin (1 mg/ml) Ifosfamide (50 mg/ml) Irinotecan HCI (20 mg/ml) Leuprolide Acetate Salt (5 mg/ml) Mechlorethamine HCI (1 mg/ml) Melphalan (5 mg/ml) Methotrexate (25 mg/ml) Mitomycin C (0.5 mg/ml) Mitoxantrone (2 mg/ml) Oxaliptin (5 mg/ml) Paclitaxel (6 mg/ml) Pemetrexed (25 mg/ml) Raltitrexed (0.5 mg/ml) Retrovir (10 mg/ml) Rituximab (10 mg/ml) Temsirolimus (25 mg/ml) Topotecan HCI (1 mg/ml) Triclosan (2 mg/ml) Trisenox (1 mg/ml) Vinblastine Sulfate (1 mg/ml) Vincristine (1 mg/ml) Vinorelbine (10 mg/ml) Zoledronic Acid (0.8 mg/ml) The following chemotherapy drugs and concentration showed breakthrough detected in less than 60 minutes: Carmustine (3.3 mg/ml) No breakthrough up to 0.3 minutes. Thiotepa (10 mg/ml) No breakthrough up to 30.9 minutes. The following hazardous drugs (opioids) and concentration had NO breakthrough detected up to 240 minutes: Fentanyl Citrate Injection (100 mcg/2 ml) and Simulated Gastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 Solution Warning: Not for Use With: Carmustine, ThioTEPA

Source page: https://510kreport.com/device/K213937
Methodology: https://510kreport.com/methodology