510(k) K252167 ยท FRO Dressing, Wound, Drug
Enhanced Silver Gelling Fiber Dressing (OTC) Extra Enhanced Silver Gelling Fiber Dressing (Prescription)
| Applicant | Qingdao Bright Moon Biomedical Materials Co., Ltd., Qingdao, CN |
| Decision | Substantially Equivalent, Dec 19, 2025 |
| Received | Jul 10, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K252167
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.