Freeform Blue Powderfree Nitrile Examination Gloves

K022671 is the FDA 510(k) clearance record for FREEFORM BLUE POWDERFREE NITRILE EXAMINATION GLOVES, a class I device, cleared for Hartalega Sdn Bhd on 2002-11-18 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 61 510(k) clearances for Hartalega Sdn Bhd, from 1989-05-31 to 2020-10-02. As of 2026-09-10, FDA records show no recalls naming K022671.