# K220541: PureZero LIMON Nitrile Powder-Free Exam Gloves, PureZero LIMON-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: 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)
- K191230: Halyard Sterling* Nitrile Powder-Free Exam Gloves, Halyard Sterling SG* Nitrile Sensi-Guard Powder-Free Exam Gloves, O&M Halyard, Inc. (2019) Summary page 6.

## Indications for use
The PureZero LIMON Nitrile Powder-Free Exam Gloves with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid claim and PureZero LIMON-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 87.6 minutes Carmustine (3.3 mg/ml), breakthrough detected at 34.3 minutes Warning: Not for Use With: Carmustine, ThioTEPA

Source page: https://510kreport.com/device/K220541
Methodology: https://510kreport.com/methodology