# K220121: Non Sterile Nitrile Powder Free Examination Gloves – Blue,Green, and Black

- Pathway: 510(k) (Traditional)
- Applicant: Aamedix Glove Sdn Bhd
- Decided: Apr 11, 2022 after 83 days
- Product code: LZA (Polymer Patient Examination Glove)
- Device class: 1
- Regulation: 21 CFR 880.6250
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K052502 (2005). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143289: Non-Sterile, Power Free Nitrile Examination Gloves-Orange, Green, Blue and Violet Color, Yty Industry (Manjung) Sdn Bhd (2015) Summary page 5.

## Indications for use
A powder-free patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Source page: https://510kreport.com/device/K220121
Methodology: https://510kreport.com/methodology