510(k) K230384 · QPC Gown, Non-Sterile, Non-Isolation, Intended To Provide Moderate Or High Barrier Protection
PolyWear® Personal Protective Level 3 Gown
| Applicant | PolyConversions, Inc., Champaign IL, US |
| Decision | Substantially Equivalent, Aug 11, 2023 |
| Received | Feb 14, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K230384
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.