# K113191: Power Free Vinyl Patient Examination Gloves, Yellow Color

- Pathway: 510(k) (Traditional)
- Applicant: Suqian Ruijang Medical Supplies Co., Ltd.
- Decided: Nov 17, 2011 after 17 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: 4 generations back to K000071 (2000). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110972: Powder Free Vinyl Patient Examination Gloves, Light Yellow Color, Ppp Medical and Safety Products Company Limited (2011) Summary page 2.

## Indications for use
Powder Free Vinyl Patient Examination Gloves, Yellow Color 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/K113191
Methodology: https://510kreport.com/methodology