# K100058: Powder Free Vinyl Patient Examination Gloves, Colored (Yellow)

- Pathway: 510(k) (Traditional)
- Applicant: Tangshan Zhongpu Plastic Products Co., Ltd.
- Decided: Mar 5, 2010 after 56 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K081156: Cadd Medication Cassette Reservoir, Smiths Medical MD, Inc. (2008). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## 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/K100058
Methodology: https://510kreport.com/methodology