Nitrile Powder Free Blue Patient Examination Gloves, Non-Sterile

K221378 is the FDA 510(k) clearance record for Nitrile Powder Free Blue Patient Examination Gloves, Non-Sterile, a class I device, cleared for Tec Gloves Industry (M) Sdn.Bhd. on 2022-09-30 under FDA product code LZA (Polymer Patient Examination Glove). FDA's definition for product code LZA reads: "A nitrile (or polymer) patient examination glove is a disposable device made of nitrile rubber or synthetic polymers 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...". FDA records list one 510(k) clearance for Tec Gloves Industry (M) Sdn.Bhd. As of 2026-09-10, FDA records show no recalls naming K221378.