510(k) K251967 ยท FXX Mask, Surgical
HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops; HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops with WrapAround Visor
| Applicant | O&M Halyard, Inc., Alpharetta GA, US |
| Decision | Substantially Equivalent, Mar 18, 2026 |
| Received | Jun 26, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K251967
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.