Powder-Free Vinyl Patient Examination Gloves

K102152 is the FDA 510(k) clearance record for POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, a class I device, cleared for Hebei Tengda Plastic Co., Ltd. on 2011-04-28 under FDA product code LYZ (Vinyl Patient Examination Glove). FDA's definition for product code LYZ reads: "A vinyl patient examination glove is a disposable device made of poly(vinyl chloride) 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 2 510(k) clearances for Hebei Tengda Plastic Co., Ltd., from 2011-04-27 to 2011-04-28. As of 2026-09-10, FDA records show one recall naming K102152.