# K100978: Powder Free Non-Sterile Vinyl Examination Glove

- Pathway: 510(k) (Traditional)
- Applicant: Jiangsu Sunshine Plastic Products, Co., Ltd.
- Decided: Aug 12, 2010 after 126 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
No predicates in its family tree.
5 later devices descend from it; 4 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K143277: Cream Stretch Vinyl Patient Examination Glove (Non-Sterile),White Vinyl Patient Examination Glove (Non-Sterile), (2015), 1 descendant of its own
- K160675: Powder free vinyl patient examination glove, colored (yellow) (2016), 0 descendants of its own
- K150934: Powder Free Vinyl Patient Examination Glove (Non?-Sterile) (2015), 0 descendants of its own
- K112741: Powder Free Vinyl Patient Examination Glove (2012), 0 descendants of its own
- K111598: Powder-Free Non-Sterile Vinyl Examination Glove (2011), 0 descendants of its own

## Indications for use
The 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 examniner.

Source page: https://510kreport.com/device/K100978
Methodology: https://510kreport.com/methodology