K262014
- 510(k) number
- K262014
- Device name
- PUREZERO* MARIN* Nitrile Powder-Free Exam Gloves; PUREZERO* MARIN-XTRA* Nitrile Powder-Free Exam Gloves
- Applicant
- O&M Halyard, Inc. GA · US
- Product code
- LZA — Polymer Patient Examination Glove
- Decision date
- 2026-07-21
- Date received
- 2026-06-15
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 1.3 MB · U.S. public domain
Also available from FDA: K262014.pdf
Official FDA record: K262014
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.