LUOFUCON® Antimicrobial Wound Gel

LUOFUCON® Wound Gel Extra is a sterile, clear amorphous hydrogel wound dressing supplied in a collapsible polypropylene tube. It maintains a moist wound environment to promote healing and contains benzalkonium chloride as a preservative. It is indicated for prescription use in managing ulcers, burns, and surgical wounds, and for OTC use in minor cuts, lacerations, and abrasions.

The device contains water, hydroxyethyl cellulose, propylene glycol, trisodium citrate, benzalkonium chloride, sodium gluconate, and disodium EDTA. It differs in composition from the predicate (which uses polyethylene glycol 400 and 3350) but shares the same hydrophilic polymer mechanism, preservative agent (benzalkonium chloride), and is supplied sterile, whereas the predicate was not.

ISO 10993-1 (biocompatibility testing for surface devices in contact with breached or compromised skin with prolonged contact); USP <51> (preservative effectiveness testing); general performance tests including appearance, weight, loss on drying, fluid affinity, pH, and sterility.