LUOFUCON® Silver Collagen Dressing

LUOFUCON® Silver Collagen Dressing is a sterile, single-use wound dressing made from bovine collagen and silver chloride. When exposed to wound exudate or sterile water, it transforms into a soft, conformable gel sheet that maintains a moist wound environment and prevents bacterial colonization. It is indicated for management of various wound types including pressure ulcers, diabetic ulcers, burns, surgical wounds, and trauma wounds.

Both the subject and predicate devices are single-layer, sheet-form, porous microstructure products made of collagen and silver chloride, sterilized by gamma radiation to SAL 10⁻⁶, and designed for single-use prescription application. The subject device employs an in-vitro antibacterial effectiveness test to demonstrate efficacy against bacteria, while the predicate device description does not explicitly detail such testing methodology.

ISO 10993-1 (biocompatibility evaluation); ISO 11137-1/-2 (radiation sterilization validation); ISO 22442 (animal-derived materials safety); FDA guidance on shelf life (real-time aging testing); VDmax25 methodology for sterilization dose establishment.

The subject device shares identical intended use, indications for use, materials (collagen and silver chloride), physical structure (porous microstructure), sterilization method (gamma radiation), and mode of action (moist wound environment maintenance with bacterial prevention) with the predicate device Puracol Plus Ag. Both are unclassified, single-use, prescription products with the same product code. The subject device's performance tests demonstrate it meets all requirements and raises no new safety or effectiveness issues compared to the predicate, supporting substantial equivalence despite minor differences in antibacterial testing documentation.