BIOBRANE Temporary Wound Dressing; BIOBRANE Glove

BIOBRANE Dressing and BIOBRANE Glove are wound dressings for covering clean partial thickness burn wounds and split-thickness donor sites. The dressing is made from an ultrathin, semipermeable, perforated silicone membrane bonded to nylon fabric with denatured porcine dermal collagen coating to provide flexibility, adherence, and a moist wound-healing environment. The glove variant is specifically designed for hand burn wounds.

Both the subject device and predicate device use identical materials and structure: a porous silicone-nylon bi-layer sheet with collagen coating. The silicone membrane creates a moisture-retaining film, the nylon provides structural support, and the collagen layer provides wound adherence. Both devices are single-use, sterilized by moist heat to SAL 10⁻⁶, have a 3-year shelf life, and are used only by trained healthcare professionals in healthcare facilities or home settings.

The device complies with ISO 10993 for biocompatibility. No other specific test standards (ASTM, IEC, etc.) are explicitly cited in this summary.

The subject device is substantially equivalent because it is identical in materials, design, principles of operation, sterilization method, and biocompatibility requirements to the predicate BIOBRANE II (K901369). The indications for use are more precisely specified in the subject device (explicitly designating split-thickness donor sites and hand wounds) but remain within the scope of the predicate's indications. Bench performance verification testing confirmed the subject device meets design specifications and demonstrates performance equivalent to the predicate device.