# K000689: Uniglove Nitrile Powder-Free Examination Gloves

- Pathway: 510(k) (Traditional)
- Applicant: N.S. Uni-Gloves Sdn. Bhd.
- Decided: Apr 28, 2000 after 59 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
No predicates in its family tree.
3 later devices descend 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)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K112012: Non-Sterile, Powder-Free Blue, Nitrile Examination Gloves (2012), 2 descendants of its own
- 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

Source page: https://510kreport.com/device/K000689
Methodology: https://510kreport.com/methodology