# K122920: Powder Free Vinyl Patient Examination Gloves, Colored (Yellow)

- Pathway: 510(k) (Traditional)
- Applicant: Hebei Leader Plastic Co., Ltd.
- Decided: Nov 30, 2012 after 67 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 K042119 (2004). 2 ancestors in all.
7 later devices descend from it; 6 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051156: Powder-Free Vinyl Patient Examination Gloves Colored (White, Yellow), Shijiazhuang Manful Light Industrial Products Co., (2005) Summary page 5.

## Most influential descendants
- K141878: Hongyun Powder-Free Yellow Vinyl Patient Examination Gloves (2014), 1 descendant of its own
- K152818: Yongchang Powder-Free Yellow Vinyl Patient Examination Gloves (2016), 0 descendants of its own
- K152719: Xinfu Powder-Free Yellow Vinyl Patient Examination Gloves (2016), 0 descendants of its own
- K152692: Powder Free Vinyl Patient Examination Gloves (Green) (2015), 0 descendants of its own
- K143347: Powder-Free Yellow Vinyl Patient Examination Gloves (2015), 0 descendants of its own

## Indications for use
Powder Free Vinyl Patient Examination Gloves. Colored (Yellow) 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/K122920
Methodology: https://510kreport.com/methodology