K250082
- 510(k) number
- K250082
- Device name
- Procedure mask/Surgical mask/Face mask
- Applicant
- Winner Medical Co., Ltd. CN
- Product code
- FXX — Mask, Surgical
- Decision date
- 2025-06-18
- Date received
- 2025-01-13
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K250082.pdf
Official FDA record: K250082
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.