K243172
- 510(k) number
- K243172
- Device name
- Halyard Purple Nitrile* Powder-Free Exam Gloves, Sterile Pairs; Halyard Purple Nitrile* Powder-Free Exam Gloves, Sterile Singles
- Applicant
- O&M Halyard, Inc. VA · US
- Product code
- LZA — Polymer Patient Examination Glove
- Decision date
- 2025-06-18
- Date received
- 2024-09-30
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K243172.pdf
Official FDA record: K243172
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.