Powder Free Latex Examination Gloves Blue (Colored), Non-Sterile, with Protein Labeling Claim of 50Ug per Dm2 of Glove

K101799 is the FDA 510(k) clearance record for POWDER FREE LATEX EXAMINATION GLOVES BLUE (COLORED), NON-STERILE, WITH PROTEIN LABELING CLAIM OF 50UG PER DM2 OF GLOVE, a class I device, cleared for Wear Safe (Malaysia) Sdn. Bhd. on 2010-09-03 under FDA product code LYY (Latex Patient Examination Glove). FDA's definition for product code LYY reads: "A latex patient examination glove is a disposable device made of natural rubber latex that may or may not bear a trace amount of residual powder, and is intended to be worn on the hand for medical purposes to provide a barrier against...". FDA records list 14 510(k) clearances for Wear Safe (Malaysia) Sdn. Bhd., from 1998-01-06 to 2017-09-29. As of 2026-09-10, FDA records show no recalls naming K101799.