# K172867: Nitrile Examination Powder Free Glove, Black, Nitrile Examination Powder Free Glove, Orange

- Pathway: 510(k) (Traditional)
- Applicant: Gmp Medicare Sdn Bhd (F25)
- Decided: May 10, 2018 after 232 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K211310: AMADEX - Nitrile Powder Free Examination Gloves Non-Sterile (Blue, Black, Orange) (2021), 0 descendants of its own

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

Source page: https://510kreport.com/device/K172867
Methodology: https://510kreport.com/methodology