K252167
- 510(k) number
- K252167
- Device name
- Enhanced Silver Gelling Fiber Dressing (OTC) Extra Enhanced Silver Gelling Fiber Dressing (Prescription)
- Applicant
- Qingdao Bright Moon Biomedical Materials Co., Ltd. CN
- Product code
- FRO — Dressing, Wound, Drug
- Decision date
- 2025-12-19
- Date received
- 2025-07-10
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Unknown
510(k) Summary (official FDA PDF): K252167.pdf
Official FDA record: K252167
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.