# K014280: Latex Examination Glove (Powdered)

- Pathway: 510(k) (Traditional)
- Applicant: Brightway Gloves Pvt., Ltd.
- Decided: Mar 20, 2002 after 83 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. The FDA summary names its predicate without a number.
- (no number) Class I Patient Examination Gloves (powdered) 80LYY that meets all the requirements of ASTM D3578: named in the summary without a submission number

## Indications for use
LATEX EXAMINATION GLOVE (POWDERED) IS A DISPOSABLE DEVICE MADE OF NATURAL LATEX INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXAMINERS HAND OR FINGER TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER AWR 18 POVMBERER WITH ARSARRARHE DUSTING POWDER USP CORN STARCH.

Source page: https://510kreport.com/device/K014280
Methodology: https://510kreport.com/methodology