# K220547: PureZero MARIN Nitrile Powder-Free Exam Gloves, PureZero MARIN-XTRA Nitrile Powder-Free Exam Gloves

- Pathway: 510(k) (Special)
- Applicant: O&M Halyard, Inc.
- Decided: Jun 2, 2022 after 97 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: 4 generations back to K051347 (2005). 8 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200633: Halyard Black-Fire Powder-Free Nitrile Exam Glove, Halyard Purple Powder-Free Nitrile Exam Glove, 0 & M Halyard, Inc. (2020) Summary page 5.

## Most influential descendants
- K262014: PUREZERO* MARIN* Nitrile Powder-Free Exam Gloves; PUREZERO* MARIN-XTRA* Nitrile Powder-Free Exam Gloves (2026), 0 descendants of its own

## Indications for use
The PureZero MARIN Nitrile Powder-Free Exam Gloves with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid claim and PureZero MARIN-XTRA Nitrile Powder-Free Exam Gloves with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid claim is a disposable device 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: Cisplatin (1 mg/ml) Cyclophosphamide (20 mg/ml) Dacarbazine (10 mg/ml) Doxorubicin HCI (2 mg/ml) Etoposide (20 mg/ml) Fluorouracil (50 mg/ml) Ifosfamide (50 mg/ml) Methotrexate (25 mg/ml) Mitomycin C (0.5 mg/ml) Mitoxantrone HCI (2 mg/ml) Paclitaxel (6 mg/ml) Vincrinstine Sulfate (1 mg/ml) Fentanyl Citrate Injection (100 mcg/2 mL) Simulated Gastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 Solution The following chemotherapy drugs and concentration showed breakthrough detected in less than 90 minutes: ThioTEPA (10 mg/ml), breakthrough detected at 88.6 minutes Carmustine (3.3 mg/ml), breakthrough detected at 55.2 minutes Warning: Not for Use With: Carmustine, ThioTEPA

Source page: https://510kreport.com/device/K220547
Methodology: https://510kreport.com/methodology