Nitril Exam Glove, Pre-Powered Color White, Nitrile Exam Glove, Pre-Powdered, Color Blue

K100975 is the FDA 510(k) clearance record for NITRIL EXAM GLOVE, PRE-POWERED COLOR WHITE, NITRILE EXAM GLOVE, PRE-POWDERED, COLOR BLUE, a class I device, cleared for Jiangsu Sunshine Plastic Products, Co., Ltd. on 2010-08-17 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 4 510(k) clearances for Jiangsu Sunshine Plastic Products, Co., Ltd., from 2010-07-02 to 2010-08-17. As of 2026-09-10, FDA records show no recalls naming K100975.