# K232319: Black Pearl Nitrile Examination Glove

- Pathway: 510(k) (Traditional)
- Applicant: Ug Global Resources Sdn. Bhd.
- Decided: Apr 22, 2024 after 263 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: 2 generations back to K000689 (2000). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112012: Non-Sterile, Powder-Free Blue, Nitrile Examination Gloves, Ug Healthcare (Usa), Inc. (2012) Summary page 5.

## Indications for use
Black Pearl Nitrile Examination Glove is a disposable device, intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

Source page: https://510kreport.com/device/K232319
Methodology: https://510kreport.com/methodology