Modified Labeling of Surgical Gloves

K894034 is the FDA 510(k) clearance record for MODIFIED LABELING OF SURGICAL GLOVES, a class I device, cleared for James River Corp. on 1989-07-14 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 15 510(k) clearances for James River Corp., from 1983-01-07 to 1989-09-15. As of 2026-09-10, FDA records show no recalls naming K894034.