Thermoplastic Elastomer (TPE) Hybrid Examination Glove

K210463 is the FDA 510(k) clearance record for Thermoplastic Elastomer (TPE) Hybrid Examination Glove, a class I device, cleared for Xuzhou Full Sun Medical Products , Ltd. on 2022-01-23 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 8 510(k) clearances for Xuzhou Full Sun Medical Products , Ltd., from 2007-07-30 to 2022-01-23. As of 2026-09-10, FDA records show no recalls naming K210463.