# K111598: Powder-Free Non-Sterile Vinyl Examination Glove

- Pathway: 510(k) (Abbreviated)
- Applicant: Lpl (Hui Zhou) Glove Co., Ltd.
- Decided: Jul 20, 2011 after 42 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 1.

## Indications for use
The powder free vinyl patient examination glove (non-sterile) is a disposable device intended for medical purposes that is worn on the examiner's band or finger to prevent contamination between patient and examiner. It is sold as non-sterile.

Source page: https://510kreport.com/device/K111598
Methodology: https://510kreport.com/methodology