# K162113: Powder Free Nitrile Examination Gloves (Blue)

- Pathway: 510(k) (Traditional)
- Applicant: Nam Viet Glove Joint Stock Company
- Decided: Nov 7, 2016 after 101 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 K100603 (2010). 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)
- K100603: RS Safe Blue Nitrile Medical Examination Gloves (Powder Free), Riverstone Resources Sdn Bhd (2010) Summary page 4.

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

Source page: https://510kreport.com/device/K162113
Methodology: https://510kreport.com/methodology