Powder free nitrile examination glove- black, non sterile

K212801 is the FDA 510(k) clearance record for Powder free nitrile examination glove- black, non sterile, a class I device, cleared for Hong Seng Gloves Sdn Bhd on 2022-01-09 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 Hong Seng Gloves Sdn Bhd, from 2021-12-01 to 2022-08-30. As of 2026-09-10, FDA records show no recalls naming K212801.