# K091431: Powder-Free, Yellow Vinyl Patient Examination Gloves

- Pathway: 510(k) (Traditional)
- Applicant: Zibo Yusheng Plastic Products Co., Ltd.
- Decided: Jul 8, 2009 after 56 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.
35 later devices descend from it; 1 cites it directly.
0 of 36 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
- K142508: Powder Free Yellow Vinyl Patient Examination Gloves (2014), 34 descendants of its own
- K150224: Blue Vinyl Gloves Powder Free (2015), 33 descendants of its own
- K163168: Vinyl Examination Gloves (White), Vinyl Examination Gloves (Blue), Vinyl Examination Gloves (Yellow) (2017), 30 descendants of its own
- K180861: Vinyl Examination Glove (Clear, Non-Colored) (2018), 9 descendants of its own
- K180849: Vinyl Examination Glove (Clear, Non-Colored) (2018), 4 descendants of its own

## Indications for use
A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or finger to prevent contamination between patient and examiner (21CFR 880.6250)

Source page: https://510kreport.com/device/K091431
Methodology: https://510kreport.com/methodology