510(k) K252534 ยท FXX Mask, Surgical
Surgical Face Mask (Ear mount)
| Applicant | Zhejiang Hangkang Medical Equipment Co., Ltd., Yiwu, CN |
| Decision | Substantially Equivalent, Mar 3, 2026 |
| Received | Aug 12, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K252534
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.