510(k) K252575 · FYA Gown, Surgical
Tuff Cuff Disposable Surgical Gowns AAMI L4 Sterile-Large (ML-L4-STL-DC-L)
| Applicant | New York Embroidery Studio (NYES), New York NY, US |
| Decision | Substantially Equivalent, Jun 4, 2026 |
| Received | Aug 14, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K252575
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.