# K161961: UniTex Non-Sterile, Powder-Free, Latex Examination Glove

- Pathway: 510(k) (Traditional)
- Applicant: Ug Global Resources Sdn. Bhd.
- Decided: May 11, 2017 after 297 days
- Product code: LYY (Latex 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 K010879 (2001). 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)
- K010879: Uniglove Powder-Free Latex Examination Gloves with Protein Content Labeling Claim (50 Micrograms or Less), N.S. Uni-Gloves Sdn. Bhd. (2001) Summary page 4.

## Indications for use
A Patient Examination Glove is a disposable device intended for medical purposes that is worn on the examiners hand or finger to prevent contamination between patient and the examiner.

Source page: https://510kreport.com/device/K161961
Methodology: https://510kreport.com/methodology