# K143131: Powder Free Nitrile Patient Examination Glove, Black Colored, Non-Sterile

- Pathway: 510(k) (Traditional)
- Applicant: Kossan International Sdn Bhd
- Decided: Feb 12, 2015 after 104 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 K060724 (2006). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121529: Black Nitrile Powder-Free Examination Gloves, Northstar Healthcare Holdings (2012) Summary page 4.

## Most influential descendants
- K213934: Pro Guard Nitrile Powder Free Examination Glove (2022), 0 descendants of its own

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

Source page: https://510kreport.com/device/K143131
Methodology: https://510kreport.com/methodology