K201324 - Antibacterial Bandage (FDA 510(k) Clearance)

K201324 is an FDA 510(k) clearance for the Antibacterial Bandage. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Jiangsu Excellence Medical Supplies Co., Ltd. (Changzhou, CN). The FDA issued a Cleared decision on February 5, 2021 after a review of 263 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.

View all Jiangsu Excellence Medical Supplies Co., Ltd. devices