# K011728: Brightway Brand Powder Free Latex Examination Gloves, Blue Non-Sterile, Protein Labeling Claim (50 Micrograms or Less) (

- Pathway: 510(k) (Traditional)
- Applicant: Brightway Holdings Sdn. Bhd.
- Decided: Jul 9, 2001 after 35 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 Powder Free Latex Examination Glove - Blue Color, Non-Sterile (containing 50 pgm or less of water extractable protein per gram) (tested for use with Chemotherapy Drugs Carmustine, Fluorouracil, Methotrexate) is a disposable examination glove which is worn on the hand of healthcare and similar personnel to prevent contamination between patient and examiner and also to protect the examiner's hands from being affected by the chemicals used in therapy. This glove is to be used in a Non Sterile environment.

Source page: https://510kreport.com/device/K011728
Methodology: https://510kreport.com/methodology