Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs (Original Blue, Cobalt Blue)

K162095 is the FDA 510(k) clearance record for Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs (Original Blue, Cobalt Blue), a class I device, cleared for Yty Industry (Manjung) Sdn Bhd on 2016-11-02 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 27 510(k) clearances for Yty Industry (Manjung) Sdn Bhd, from 1989-07-14 to 2023-03-25. As of 2026-09-10, FDA records show no recalls naming K162095.