# K102558: Powder Free Vinyl Patient Examination Gloves, Colored (White)

- Pathway: 510(k) (Traditional)
- Applicant: Tangshan Hengda Plastic Products Co., Ltd.
- Decided: Nov 12, 2010 after 66 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.
3 later devices descend from it; 3 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)
- K051156: Powder-Free Vinyl Patient Examination Gloves Colored (White, Yellow), Shijiazhuang Manful Light Industrial Products Co., (2005) Summary page 1.

## Most influential descendants
- K143346: Powder-Free White Vinyl Patient Examination Gloves (2015), 0 descendants of its own
- K141613: Goldenline Powder-Free White Vinyl Patient Examination Gloves (2014), 0 descendants of its own
- K113194: Powder Free Vinyl Patient Examination Gloves, White Color (2012), 0 descendants of its own

## Indications for use
Powder Free Vinyl Patient Examination Gloves. Colored (White) 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/K102558
Methodology: https://510kreport.com/methodology