PUREZERO* MARIN* Nitrile Powder-Free Exam Gloves; PUREZERO* MARIN-XTRA* Nitrile Powder-Free Exam Gloves— 510(k) K262014
Substantially EquivalentO&M Halyard, Inc.
FDA 510(k) clearance K262014 for PUREZERO* MARIN* Nitrile Powder-Free Exam Gloves; PUREZERO* MARIN-XTRA* Nitrile Powder-Free Exam Gloves, Substantially Equivalent on 2026-07-21. Applicant: O&M Halyard, Inc.. Device class: 1.
Summary
O&M Halyard's clearance covers PUREZERO MARIN and PUREZERO MARIN-XTRA Nitrile Powder-Free Exam Gloves, filed under LZA, polymer patient examination gloves. The record doesn't say how the two differ.
Class I, 21 CFR 880.6250. General Hospital is both the classification panel and the review panel, and it came in as a Special 510(k).
O&M Halyard filed from Alpharetta, Georgia. Review took 36 calendar days (June 15 to July 21, 2026).
Clearance details
- Applicant
- O&M Halyard, Inc.
- Product code
- Product code LZA
- Device class
- Class 1
- Regulation
- 21 CFR 880.6250
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Alpharetta, GA, US
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Adverse events under product code LZA
product code LZA- Other
- 1
- Total
- 1
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.