# K160675: Powder free vinyl patient examination glove, colored (yellow)

- Pathway: 510(k) (Traditional)
- Applicant: Kaixing Plastic Products Co., Litd.
- Decided: Aug 2, 2016 after 145 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: 2 generations back to K100978 (2010). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143277: Cream Stretch Vinyl Patient Examination Glove (Non-Sterile),White Vinyl Patient Examination Glove (Non-Sterile),, Lifestyle Safety Products (Hui Zhou) Co., Ltd. (2015) Summary page 4.

## Indications for use
Powder free vinyl patient examination glove, colored (yellow) is a non-sterile, disposable device intended for medical purposes that is worn on the examiner’s hand to prevent contamination between patient and examiner.

Source page: https://510kreport.com/device/K160675
Methodology: https://510kreport.com/methodology