510(k) K212460 · FXX Mask, Surgical
Medical Surgical Mask (Model: ZKM-U01(non-sterilized type 17.5cm×9.5cm))
| Applicant | Guangzhou Zhengkang Medical Equipment Co.,Ltd, Guangzhou, CN |
| Decision | Substantially Equivalent, Nov 5, 2021 |
| Received | Aug 5, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K212460
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.