510(k) K253243 · FYA Gown, Surgical
Cardinal Health Poly Reinforced Surgical Gown
| Applicant | Cardinal Health 200, LLC, Waukegan IL, US |
| Decision | Substantially Equivalent, Apr 28, 2026 |
| Received | Sep 29, 2025 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K253243
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.