# K063810: Yulex Latex Powder-Free Exam Gloves

- Pathway: 510(k) (Traditional)
- Applicant: Yulex Corporation
- Decided: Apr 18, 2008 after 483 days
- Product code: OIG (Powder-Free Guayle Rubber 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 powder-free latex patient examination glove: named in the summary without a submission number

## Indications for use
A disposable device made from guayule natural rubber. The device 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 potentially infectious materials and other contaminants.

Source page: https://510kreport.com/device/K063810
Methodology: https://510kreport.com/methodology