# K031335: Powder Free Latex Exam Gloves

- Pathway: 510(k) (Traditional)
- Applicant: Tan Sin Lian Industries Sdn. Bhd.
- Decided: Oct 16, 2003 after 171 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
The Powder Free Patient Examination Gloves is a disposable device made of natural rubber latex that may bear a trace amount of glove powder and is intended to be worn on the hand for medical purposes to provide a barrier against potential infectious materials and other Contaminants.

Source page: https://510kreport.com/device/K031335
Methodology: https://510kreport.com/methodology