510(k) K250082 ยท FXX Mask, Surgical
Procedure mask/Surgical mask/Face mask
| Applicant | Winner Medical Co., Ltd., Shenzhen, CN |
| Decision | Substantially Equivalent, Jun 18, 2025 |
| Received | Jan 13, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K250082
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.