# K032938: Brightway Brand Latex Examination Glove-(Powdered, Sterile), Containing 150 Ugm or Less of Water Extractable Protein Per

- Pathway: 510(k) (Traditional)
- Applicant: Brightway Holdings Sdn. Bhd.
- Decided: Nov 20, 2003 after 59 days
- Product code: LYY (Latex 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
BRIGHTWAYTM Brand Latex Examination Gloves (Powdered, sterile) containing 150 pgm or less of water extractable protein per gram is a disposable patient examination glove made of Natural Rubber which is worn on the hand of healthcare and similar personnel to prevent contamination from patient and examiner.

Source page: https://510kreport.com/device/K032938
Methodology: https://510kreport.com/methodology