# K120584: Power Free Stretch Vinyl Patient Examination Gloves

- Pathway: 510(k) (Traditional)
- Applicant: Wealth on (Jiangsu) Co., Ltd.
- Decided: Jul 10, 2012 after 134 days
- Product code: LYZ (Vinyl 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
Longest line of descent: 4 generations back to K000071 (2000). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110219: Powder Free Vinyl Patient Examination Gloves, Wealth on (Jiangsu) Co., Ltd. (2011)

## Indications for use
The powder free light yellow stretch vinyl patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. It has light yellow color and is sold as non sterile.

Source page: https://510kreport.com/device/K120584
Methodology: https://510kreport.com/methodology