510(k) K212464 ยท QPC Gown, Non-Sterile, Non-Isolation, Intended To Provide Moderate Or High Barrier Protection
Dukal Corporation AAMI Level 4 Open-Back Protective Gown
| Applicant | Dukal Corporation, Ronkonkoma NY, US |
| Decision | Substantially Equivalent, Mar 30, 2022 |
| Received | Aug 6, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K212464
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.