510(k) K253398 ยท FXX Mask, Surgical
Disposable Surgical Mask (Non-Sterile) (EFX3PLBLKMSK300)
| Applicant | Efofex, Inc., Rogers AR, US |
| Decision | Substantially Equivalent, Feb 19, 2026 |
| Received | Sep 30, 2025 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K253398
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.