510(k) K221819 ยท FYA Gown, Surgical
35g Standard SMMS Surgical Gown; 35g Reinforced SMMS Surgical Gown;43g Standard SMMS Surgical Gown;43g Reinforced SMMS Surgical Gown ;50g Standard SMMS Surgical Gown; 50g Reinforced SMMS Surgical Gown;BVB Surgical Gown
| Applicant | Winner Medical Co., Ltd., Guangdong, CN |
| Decision | Substantially Equivalent, Sep 19, 2022 |
| Received | Jun 23, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K221819
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.