Derma Prene Isotouch Green Sterile Powder-Free Polyisoprene Surgical Goves, Tested for U

K111139 is the FDA 510(k) clearance record for DERMA PRENE ISOTOUCH GREEN STERILE POWDER-FREE POLYISOPRENE SURGICAL GOVES, TESTED FOR U, a class I device, cleared for Ansell Healthcare Products, Inc. on 2011-09-02 under FDA product code KGO (Surgeon'S Gloves). FDA's definition for product code KGO reads: "A surgeon's glove is a disposable device made of natural rubber latex or synthetic polymers that may or may not bear powder to facilitate donning, and it is intended to be worn on the hands, usually in surgical settings, to provide a...". FDA records list 39 510(k) clearances for Ansell Healthcare Products, Inc., from 2000-07-31 to 2023-10-20. As of 2026-09-10, FDA records show 3 recalls naming K111139.