Pure Advantage Nitrile Hypoallergenic Surgical Glove

K972009 is the FDA 510(k) clearance record for PURE ADVANTAGE NITRILE HYPOALLERGENIC SURGICAL GLOVE, a class I device, cleared for Tillotson Healthcare Corp. on 1997-09-12 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 20 510(k) clearances for Tillotson Healthcare Corp., from 1995-12-21 to 2002-07-05. As of 2026-09-10, FDA records show no recalls naming K972009.