K250082 is an FDA 510(k) clearance for the Procedure mask/Surgical mask/Face mask. This device is classified as a Mask, Surgical (Class II - Special Controls, product code FXX).
Submitted by Winner Medical Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on June 18, 2025, 156 days after receiving the submission on January 13, 2025.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K250082 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 13, 2025 |
| Decision Date | June 18, 2025 |
| Days to Decision | 156 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FXX - Mask, Surgical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4040 |