K252941
- 510(k) number
- K252941
- Device name
- HALYARD* Adult Face Mask with SO SOFT* Lining and SO SOFT* Earloops
- Applicant
- O&M Halyard, Inc. GA · US
- Product code
- FXX — Mask, Surgical
- Decision date
- 2025-12-11
- Date received
- 2025-09-15
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K252941.pdf
Official FDA record: K252941
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.