510(k) K252650 ยท FXX Mask, Surgical
Disposable Medical Face Mask
| Applicant | Makrite Industries, Inc., New Taipei, TW |
| Decision | Substantially Equivalent, Jan 5, 2026 |
| Received | Aug 22, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K252650
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.