510(k) K192290 ยท FYA Gown, Surgical
50g SMS Standard Surgical Gown, 45g SMS Surgical Gown with Reinforcement, 68g BVB Surgical Gown, 68g BVB Splicing Surgical Gown
| Applicant | Xuchang Zhengde Environstar Medical Products Co., Ltd., Xuchang, CN |
| Decision | Substantially Equivalent, Apr 30, 2020 |
| Received | Aug 23, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K192290
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.