# K141878: Hongyun Powder-Free Yellow Vinyl Patient Examination Gloves

- Pathway: 510(k) (Traditional)
- Applicant: Tangshan Hongyun Plastic Products Co., Ltd.
- Decided: Dec 24, 2014 after 166 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: 3 generations back to K042119 (2004). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122920: Powder Free Vinyl Patient Examination Gloves, Colored (Yellow), Hebei Leader Plastic Co., Ltd. (2012) Summary page 4.

## Most influential descendants
- K152692: Powder Free Vinyl Patient Examination Gloves (Green) (2015), 0 descendants of its own

## Indications for use
Powder-Free Yellow Vinyl Patient Examination Gloves is a non sterile 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/K141878
Methodology: https://510kreport.com/methodology