# K070043: Powder Free Vinyl Patient Examination Gloves, White

- Pathway: 510(k) (Traditional)
- Applicant: Super Safe Plastic Products Co., Ltd.
- Decided: Feb 8, 2007 after 36 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: 1 generation back to K000071 (2000). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000071: Synthetic Powder Free (White) Vinyl Patient Examination Gloves, Shijiazhuang Great Eagle Plastic Products Co., Ltd. (2000) 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/K070043
Methodology: https://510kreport.com/methodology