# K143277: Cream Stretch Vinyl Patient Examination Glove (Non-Sterile),White Vinyl Patient Examination Glove (Non-Sterile),

- Pathway: 510(k) (Traditional)
- Applicant: Lifestyle Safety Products (Hui Zhou) Co., Ltd.
- Decided: Jul 29, 2015 after 257 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 K100978 (2010). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100978: Powder Free Non-Sterile Vinyl Examination Glove, Jiangsu Sunshine Plastic Products, Co., Ltd. (2010) Summary page 4.

## Most influential descendants
- K160675: Powder free vinyl patient examination glove, colored (yellow) (2016), 0 descendants of its own

## Indications for use
The Cream Stretch Vinyl Patient Examination Glove (Non-Sterile) and White Vinyl Patient Examination Glove (Non-Sterile) are disposable devices intended for medical purposes that are worn on the examiner's hand to prevent contamination between patient and examiner. They are both sold as non-sterile.

Source page: https://510kreport.com/device/K143277
Methodology: https://510kreport.com/methodology