# K131344: Powder Free Yellow Synthetic Vinyl Patient Examination Gloves

- Pathway: 510(k) (Traditional)
- Applicant: Shijiazhuang Wally Plastics Co., Ltd.
- Decided: Jan 30, 2014 after 266 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.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110945: Powder-Free Yellow Synthetic Vinyl Patient Examination Gloves, Zhaoyang Plastic Co., Ltd. (2011) Summary page 2.

## Indications for use
Powder Free Yellow Synthetic 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/K131344
Methodology: https://510kreport.com/methodology