510(k) K222128 ยท QPC Gown, Non-Sterile, Non-Isolation, Intended To Provide Moderate Or High Barrier Protection
Protective Gown AAMI Level 4
| Applicant | Kenpax International Limited, Hong Kong, CN |
| Decision | Substantially Equivalent, Aug 8, 2023 |
| Received | Jul 18, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K222128
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.