# K111240: Disposable Powder Free Vinyl Synthetic Examination Glove, Blue Color

- Pathway: 510(k) (Abbreviated)
- Applicant: Xuzhou Full Sun Medical Products, Ltd.
- Decided: Jul 14, 2011 after 72 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: 1 generation back to K963751 (1996). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K963751: PT Synthetic Medical Gloves, Powder Free, Shanghai PT Plastics Enterprise Company, Ltd. (1996) Summary page 1.

## Indications for use
A PATIENT EXAMINATION GLOVES IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXAMINER'S HAND OR FINGERS TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.

Source page: https://510kreport.com/device/K111240
Methodology: https://510kreport.com/methodology