# K162146: Brightway Brand Nitrile Examination Gloves, Powder Free (Lavender)

- Pathway: 510(k) (Traditional)
- Applicant: Brightway Holdings Sdn. Bhd.
- Decided: Jan 5, 2017 after 157 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 K051347 (2005). 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)
- K081260: Kimberly-Clark *Lavender* Nitrile Power-Free Exam Gloves, Kimberly-Clark Corp. (2008) Summary page 5.

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

Source page: https://510kreport.com/device/K162146
Methodology: https://510kreport.com/methodology