# K213144: Biodegradable Powder Free Vinyl Examination Gloves Blue, Green and White Colors

- Pathway: 510(k) (Traditional)
- Applicant: Shen Wei USA, Inc.
- Decided: Dec 22, 2021 after 86 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
A disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. The device is single use only.

Source page: https://510kreport.com/device/K213144
Methodology: https://510kreport.com/methodology