# K100057: Powder-Free Vinyl Patient Examination Gloves, Colored (Yellow)

- Pathway: 510(k) (Traditional)
- Applicant: Tangshan Kangyuan Glove Co., Ltd.
- Decided: Jul 8, 2010 after 181 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.
No later device cites it as a predicate yet.
0 of 3 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). Our reading of the summary gave K001156, FDA’s number for Phoenix Hemodialysis Delivery System, Gambro Cartridge for… (Gambro Renal Products). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Powder-Free Vinyl Patient Examination Gloves (White, Yellow)”.

## Indications for use
Powder free vinyl 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 examiner.

Source page: https://510kreport.com/device/K100057
Methodology: https://510kreport.com/methodology