Sterile Latex Surgical Gloves (Powdered) with Protein Content Labeling Claim (100 Micrograms or Less)

K011066 is the FDA 510(k) clearance record for STERILE LATEX SURGICAL GLOVES (POWDERED) WITH PROTEIN CONTENT LABELING CLAIM (100 MICROGRAMS OR LESS), a class I device, cleared for Smart Glove Corp. Sdn Bhd on 2001-09-11 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 27 510(k) clearances for Smart Glove Corp. Sdn Bhd, from 1998-03-13 to 2009-07-27. As of 2026-09-10, FDA records show no recalls naming K011066.