510(k) K211538 ยท FYC Gown, Isolation, Surgical
Protect X Level 3 Isolation Gown
| Applicant | Azac Group, City Of Industry CA, US |
| Decision | Substantially Equivalent, Nov 17, 2021 |
| Received | May 18, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K211538
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.