510(k) K213832 ยท FYC Gown, Isolation, Surgical
AAMI3 Isolation Gown
| Applicant | Hubei Xinxin Non-Woven Co., Ltd., Xiantao, CN |
| Decision | Substantially Equivalent, May 16, 2022 |
| Received | Dec 9, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K213832
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.