510(k) K242146

BIOBRANE Temporary Wound Dressing; BIOBRANE Glove by Smith & Nephew Medical Limited — Product Code KGN

K242146 is an FDA 510(k) premarket notification submitted by Smith & Nephew Medical Limited for the device "BIOBRANE Temporary Wound Dressing; BIOBRANE Glove". The FDA issued a decision of Substantially Equivalent on December 17, 2024. The device falls under product code KGN (Wound Dressing With Animal-Derived Material(S)), a Class U device. Smith & Nephew Medical Limited has at least 10 other 510(k) clearances on record.