510(k) K252941 ยท FXX Mask, Surgical
HALYARD* Adult Face Mask with SO SOFT* Lining and SO SOFT* Earloops
| Applicant | O&M Halyard, Inc., Alpharetta GA, US |
| Decision | Substantially Equivalent, Dec 11, 2025 |
| Received | Sep 15, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K252941
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.