# K112012: Non-Sterile, Powder-Free Blue, Nitrile Examination Gloves

- Pathway: 510(k) (Traditional)
- Applicant: Ug Healthcare (Usa), Inc.
- Decided: Mar 21, 2012 after 252 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 K000689 (2000). 1 ancestor in all.
2 later devices descend from it; 2 cite 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)
- K000689: Uniglove Nitrile Powder-Free Examination Gloves, N.S. Uni-Gloves Sdn. Bhd. (2000) Summary page 2.

## Most influential descendants
- K232319: Black Pearl Nitrile Examination Glove (2024), 0 descendants of its own
- K162510: Non-Sterile, Powder-Free, Nitrile Examination Gloves, Blue (2017), 0 descendants of its own

## Indications for use
Non-Sterile, Powder-Free, Nitrile Examination Gloves Blue 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/K112012
Methodology: https://510kreport.com/methodology