510(k) K210148 ยท FYC Gown, Isolation, Surgical
Flosteril Poly-reinforced Isolation Gowns Model 8120 (Catalogue Number 8120400), Flosteril Poly-reinforced Isolation Gowns Model (Catalogue Number 8120410), Flosteril Poly-reinforced Isolation Gowns Model (Catalogue Number 8120430), Flosteril Poly-reinforced Isolation Gowns Model (Catalogue Number 8
| Applicant | Flomak Tekstil Makine Muh. Mum. Taah. San. Tic. Ltd. Sti., Istanbul, TR |
| Decision | Substantially Equivalent, Apr 13, 2022 |
| Received | Jan 21, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K210148
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.