# K150934: Powder Free Vinyl Patient Examination Glove (Non?-Sterile)

- Pathway: 510(k) (Traditional)
- Applicant: Lpl (Hui Zhou) Glove
- Decided: Dec 21, 2015 after 259 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.
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)
- K100978: Powder Free Non-Sterile Vinyl Examination Glove, Jiangsu Sunshine Plastic Products, Co., Ltd. (2010) Summary page 4.

## Indications for use
A 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/K150934
Methodology: https://510kreport.com/methodology