510(k) K214116 ยท FYC Gown, Isolation, Surgical
AAMI4 Isolation Gown
| Applicant | Hubei Xinxin Non-Woven Co., Ltd., Xiantao, CN |
| Decision | Substantially Equivalent, Oct 11, 2022 |
| Received | Dec 30, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K214116
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.