# K210775: White Nitrile Powder Free Patient Examination Glove, Non Sterile

- Pathway: 510(k) (Traditional)
- Applicant: Onetexx Sdn Bhd
- Decided: Jun 28, 2021 after 105 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: 4 generations back to K993247 (1999). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171615: Xingyu Nitrile Powder Free Patient Examination Gloves, White color, Shandong Xingyu Gloves Co., Ltd. (2017) Summary page 4.

## Indications for use
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Source page: https://510kreport.com/device/K210775
Methodology: https://510kreport.com/methodology