# K211310: AMADEX - Nitrile Powder Free Examination Gloves Non-Sterile (Blue, Black, Orange)

- Pathway: 510(k) (Traditional)
- Applicant: Megine Industries Sdn Bhd
- Decided: Jun 16, 2021 after 47 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: 1 generation back to K172867 (2018). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172867: Nitrile Examination Powder Free Glove, Black, Nitrile Examination Powder Free Glove, Orange, Gmp Medicare Sdn Bhd (F25) (2018)

## Indications for use
The 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/K211310
Methodology: https://510kreport.com/methodology