Biodegradable DriTek Powder Free Nitrile Examination Glove, Low Dermatitis Potential Claim, Blue

K202081 is the FDA 510(k) clearance record for Biodegradable DriTek Powder Free Nitrile Examination Glove, Low Dermatitis Potential Claim, Blue, a class I device, cleared for Shen Wei USA, Inc. on 2021-03-19 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 58 510(k) clearances for Shen Wei USA, Inc., from 1989-05-25 to 2022-05-28. As of 2026-09-10, FDA records show no recalls naming K202081.