# K122396: Powered Vinyl Patient Examination Gloves, Clear (Non-Colored)

- Pathway: 510(k) (Traditional)
- Applicant: Wealth on (Jiangsu) Co., Ltd.
- Decided: Jan 31, 2013 after 177 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: 8 generations back to K893822 (1989). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081657: Powdered Vinyl Patient Examination Gloves, (Light Yellow), Jiangsu Cureguard Glove Co., Ltd. (2008) Summary page 1.
- K110219: Powder Free Vinyl Patient Examination Gloves, Wealth on (Jiangsu) Co., Ltd. (2011) Summary page 2.

## Indications for use
The powdered vinyl patient examination glove, clear (non-colored) 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. The powder is made from cornstarch. It is color free and is sold as non sterile.

Source page: https://510kreport.com/device/K122396
Methodology: https://510kreport.com/methodology