# K990540: Brightway Brand Latex Examination Glove (Low Protein)

- Pathway: 510(k) (Traditional)
- Applicant: Brightway Holdings Sdn. Bhd.
- Decided: Apr 9, 1999 after 46 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
Brightway™ Brand Latex Examination Glove, Powdered is a disposable patient examination glove which contains 150 ugm or less of total extractable protein per gram, that is worn on the hand of healthcare and similar personnel to prevent contamination between patient and examiner.

Source page: https://510kreport.com/device/K990540
Methodology: https://510kreport.com/methodology