Enhanced Silver Gelling Fiber Dressing (OTC) Extra Enhanced Silver Gelling Fiber Dressing (Prescription)

Enhanced Silver Gelling Fiber Dressing is a soft, sterile, conformable wound dressing made of sodium carboxymethyl cellulose fibers with 1.2% ionic silver that absorbs wound fluid, creates a moist gel environment, and releases silver ions to reduce bacterial growth for up to seven days. It is available in both over-the-counter formulation for minor wounds (abrasions, lacerations, minor cuts, minor burns) and prescription formulation for more serious wounds including diabetic ulcers, pressure ulcers, surgical wounds, traumatic wounds, and bleeding-prone wounds.

The subject device contains sodium carboxymethyl cellulose fibers with strengthening polyester layer and 1.2% ionic silver, compared to the predicate which uses Hydrofiber™ with 1.2% ionic silver plus EDTA and benzethonium chloride. Both achieve similar liquid absorbency (subject: 20.55 g/100cm², predicate: 20.26 g/100cm²), maintain moist wound healing environments, inhibit bacterial growth for seven days, are sterilized by radiation at SAL 10⁻⁶, and meet identical biocompatibility requirements per ISO 10993-1.

Biocompatibility testing per ISO 10993-1 (cytotoxicity, sensitization, irritation, acute/subacute systemic toxicity, implantation, material-mediated pyrogenicity); liquid absorbency per EN 13726-1-2002; loss on drying per USP <731>; pH per USP <791>; antimicrobial efficacy per AATCC 100-2019.

The subject device is substantially equivalent because it demonstrates the same intended uses, mode of action, single-use design, antibacterial duration, sterilization method, and biocompatibility profile as the predicate AQUACEL Ag+ EXTRA. Performance bench testing confirms the device meets all design specifications and complies with applicable standards, demonstrating it is as safe and effective as the predicate device despite minor differences in component formulation.