# K051923: Powdered Vinyl Patient Examination Gloves White (Non-Colored)

- Pathway: 510(k) (Traditional)
- Applicant: Shijiazhuang Wonder Plastic Co., Ltd.
- Decided: Aug 16, 2005 after 32 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: 6 generations back to K893822 (1989). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032907: Fuguan (Brand) Powdered Vinyl Patient Examination Gloves, Shijiazhuang Fuguan Plastic Products Co., Ltd. (2003) Summary page 1.

## Indications for use
Powdered 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.

Source page: https://510kreport.com/device/K051923
Methodology: https://510kreport.com/methodology