# K163267: Nitrile Examination Glove

- Pathway: 510(k) (Traditional)
- Applicant: Brightway Holdings Sdn. Bhd.
- Decided: Mar 24, 2017 after 123 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: 3 generations back to K062764 (2007). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143477: Nitrile Patient Examination gloves, Powderfree, Blue color, Primus Gloves Pvt Limited (2016) Summary page 5.

## Indications for use
BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES, POWDER FREE (BLUE) is a disposable device intended for medical purpose to be worn on the examiners hand or finger to prevent contamination between the patient and the examiner.

Source page: https://510kreport.com/device/K163267
Methodology: https://510kreport.com/methodology