# K262014: 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: Jul 21, 2026 after 36 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). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K220547: PureZero MARIN Nitrile Powder-Free Exam Gloves, PureZero MARIN-XTRA Nitrile Powder-Free Exam Gloves, O&M Halyard, Inc. (2022) Summary page 7.

## Indications for use
PUREZERO* MARIN* Nitrile Powder-Free Exam Gloves - Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid Fluid. The glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. Gloves have been tested for use with chemotherapy drugs, Fentanyl Citrate, and a 50/50 mixture of Fentanyl Citrate and Simulated Gastric Fluid using ASTM D6978-05. The following chemicals (chemotherapy and non-chemotherapy drugs) have been tested with these gloves: Chemotherapy Drugs Concentration mg/mL Breakthrough Detection Time in Minutes 1 Cisplatin, Img/mL (1,000 ppm) >240min 2 Cyclophosphamide (Cytoxan) 20mg/mL (20,000 ppm) >240min 3 Dacarbazine (DTIC) 10mg/mL (10,000 ppm) >240min 4 Doxorubicin HCI (Adriamycin) 2mg/mL (2,000 ppm) >240min 5 Etoposide (Toposar) 20mg/mL (20,000 ppm) >240min 6 Fluorouracil (5 Flu) 50mg/mL (50,000 ppm) >240min 7 Ifosfamide (IFEX) 50mg/mL (50,000 ppm) >240min 8 Methotrexate 25mg/mL (25,000 ppm) >240min 9 Mitomycin C 0.5 mg/mL (500 ppm) >240min 10 Mitoxantrone HCI 2mg/mL (2,000 ppm) >240min 11 Paclitaxel (Taxol) 6mg/mL (6,000 ppm) >240min 12 Vincristine Sulphate Img/mL (1,000 ppm ) >240 min 13 Carmustine 3.3mg/mL (3,300 ppm) 40 min 14 Thiotepa 10mg/mL (10,000 ppm) 88.6 min Non-chemotherapy Drugs Concentration mg/mL Breakthrough Detection Time in Minutes 1 Fentanyl Citrate Injection 100mcg/2mL >240min 2 Simulated Gastric Acid Fluid / 50% (v/v) mixture Fentanyl Citrate Injection Mix 50/50 Solution >240min The following chemotherapy drugs and concentration showed breakthrough detected in less than 90 minutes: Carmustine 3.3mg/mL (3,300 ppm), breakthrough detected at 40 minutes Thiotepa 10mg/mL (10,000 ppm), breakthrough detected at 88.6 minutes Warning: Not for use with Carmustine and Thiotepa PUREZERO* MARIN-XTRA¥ Nitrile Powder-Free Exam Gloves The glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. Gloves have been tested for use with chemotherapy drugs, Fentanyl Citrate, and a 50/50 mixture of Fentanyl Citrate and Simulated Gastric Fluid using ASTM D6978-05. The following chemicals (chemotherapy and non-chemotherapy drugs) have been tested with these gloves: Chemotherapy Drugs Concentration mg/mL Breakthrough Detection Time in Minutes 1 Cisplatin, Img/mL (1,000 ppm) >240min 2 Cyclophosphamide (Cytoxan) 20mg/mL (20,000 ppm) >240min 3 Dacarbazine (DTIC) 10mg/mL (10,000 ppm) >240min 4 Doxorubicin HCI (Adriamycin) 2mg/mL (2,000 ppm) >240min 5 Etoposide (Toposar) 20mg/mL (20,000 ppm) >240min 6 Fluorouracil (5 Flu) 50mg/mL (50,000 ppm) >240min 7 Ifosfamide (IFEX) 50mg/mL (50,000 ppm) >240min 8 Methotrexate 25mg/mL (25,000 ppm) >240min 9 Mitomycin C 0.5 mg/mL (500 ppm) >240min 10 Mitoxantrone HCI 2mg/mL (2,000 ppm) >240min 11 Paclitaxel (Taxol) 6mg/mL (6,000 ppm) >240min 12 Vincristine Sulphate Img/mL (1,000 ppm ) >240 min 13 Carmustine 3.3mg/mL (3,300 ppm) 40 min 14 Thiotepa 10mg/mL (10,000 ppm) 88.6 min Non-chemotherapy Drugs Concentration mg/mL Breakthrough Detection Time in Minutes 1 Fentanyl Citrate Injection 100mcg/2mL >240min 2 Simulated Gastric Acid Fluid / 50% (v/v) mixture Fentanyl Citrate Injection Mix 50/50 Solution >240min The following chemotherapy drugs and concentration showed breakthrough detected in less than 90 minutes: Carmustine 3.3mg/mL (3,300 ppm), breakthrough detected at 40 minutes Thiotepa 10mg/mL (10,000 ppm), breakthrough detected at 88.6 minutes Warning: Not for use with Carmustine and Thiotepa

Source page: https://510kreport.com/device/K262014
Methodology: https://510kreport.com/methodology