Enhanced Silver Gelling Fiber Dressing (OTC) Extra Enhanced Silver Gelling Fiber Dressing (Prescription)— 510(k) K252167

Substantially Equivalent

Qingdao Bright Moon Biomedical Materials Co., Ltd.

FDA 510(k) clearance K252167 for Enhanced Silver Gelling Fiber Dressing (OTC) Extra Enhanced Silver Gelling Fiber Dressing (Prescription), Substantially Equivalent on 2025-12-19. Applicant: Qingdao Bright Moon Biomedical Materials Co., Ltd..

Clearance details

Applicant: Qingdao Bright Moon Biomedical Materials Co., Ltd.
Product code: Code FRO
Advisory panel: Unknown
Date received: 2025-07-10
Decision date: 2025-12-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Qingdao, CN

Download summary PDF View on FDA.gov ↗

Adverse events under product code FRO

product code FRO

Death: 30
Injury: 653
Malfunction: 479
Other: 11
Total: 1,173

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.