BIOTECH Nitrile Examination Gloves

K202419 is the FDA 510(k) clearance record for BIOTECH Nitrile Examination Gloves, a class I device, cleared for Tk Hitech Technology Co., Ltd. on 2021-04-16 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 Tk Hitech Technology Co., Ltd. As of 2026-09-10, FDA records show no recalls naming K202419.