# K070046: Powdered  Vinyl Patient Glove

- Pathway: 510(k) (Traditional)
- Applicant: Shijiazhuang Lianhe Shunda Plastic Products Co., L
- Decided: Feb 7, 2007 after 35 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 K893822 (1989). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983645: Synthetic Powdered Vinyl Patient Examination Gloves, Shijiazhuang Great Eagle Plastic Products Co., Ltd. (1998) Summary page 1.

## Indications for use
A patient examination glove is disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Source page: https://510kreport.com/device/K070046
Methodology: https://510kreport.com/methodology