K252167 - Enhanced Silver Gelling Fiber Dressing (OTC) Extra Enhanced Silver Gelling Fiber Dressing (Prescription) (FDA 510(k) Clearance)

K252167 is an FDA 510(k) clearance for the Enhanced Silver Gelling Fiber Dressing (OTC) Extra Enhanced Silver Gelling Fi.... Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Qingdao Bright Moon Biomedical Materials Co., Ltd. (Qingdao, CN). The FDA issued a Cleared decision on December 19, 2025 after a review of 162 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

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