510(k) K232824 ยท FXX Mask, Surgical
FLUIDSHIELD* 1 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, White (41802); FLUIDSHIELD* 1 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, White, Wrap Around Visor (41803); FLUIDSHIELD* 1 Surgical Mask with SO SOFT* Lining, White, (41805)
| Applicant | Owens & Minor (O&M) Halyard, Inc., Mechanicsville VA, US |
| Decision | Substantially Equivalent, Jul 2, 2024 |
| Received | Sep 13, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K232824
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.