IWD-Gel™

IWD-Gel™ is a golden brown, scented, semi-transparent wound dressing gel intended to cleanse and moisten the wound bed to provide a moist healing environment. It is indicated for prescription use on light to moderately exudating wounds including diabetic foot ulcers, leg ulcers, pressure ulcers, and burns, and for over-the-counter use on minor cuts, abrasions, lacerations, and minor burns.

The device is a non-sterile, single-use gel dressing made with a non-absorbable hydropolymer, natural surfactants, and preservatives including PHMB, Quercus robur extract, and thyme oil. It shares the same product code (FRO), similar design and dimensions, and comparable materials to the predicate devices—all are amorphous wound gels with surfactants and antimicrobial preservatives in tube configurations.

Biocompatibility testing per ISO 10993-1 covering cytotoxicity, sensitization, irritation, acute systemic toxicity, material-mediated pyrogenicity, subacute/subchronic toxicity, and implantation; USP <51>, <791>, <911>, <731>, <841> for shelf-life, pH, viscosity, loss on drying, and specific gravity; and an animal wound healing study.

IWD-Gel™ is substantially equivalent to the predicate devices (Medline Burn and Wound Gel K173911 and AmeriGel® K092086) because it has identical intended uses, similar technological characteristics as a moist gel dressing, the same product code and regulatory classification, comparable materials and design, and performs the same function of providing a moist wound environment without raising new safety or efficacy concerns based on non-clinical testing including biocompatibility and animal wound healing studies.