# K112005: Non-Sterile, Powder-Free, Green Latex Examination Gloves with Protein Content Labeling Claim (50 Micrograms or Less)

- Pathway: 510(k) (Traditional)
- Applicant: Ug Healthcare (Usa), Inc.
- Decided: Mar 21, 2012 after 252 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 K010881 (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)
- K010881: Uniglove Polymer Coated Powder-Free Latex Examination Gloves with Protein Content Labeling Claim (50 Micrograms or Less), N.S. Uni-Gloves Sdn. Bhd. (2001) Summary page 2.

## Indications for use
The Non-Sterile, Powder-Free, Latex Examination Gloves, Green and with Protein Labeling Claim (50 micrograms or less total water extractable protein per gram of glove), is a disposable device intended for Medical Purposes that is worn on the examiners hand to prevent contamination between patient and examiner.

Source page: https://510kreport.com/device/K112005
Methodology: https://510kreport.com/methodology