# K222442: DISPOSABLE VINYL EXAMINATION GLOVES (Pink, Black, Blue)

- Pathway: 510(k) (Traditional)
- Applicant: Anhui Bytech Medical Supplies Co., Ltd.
- Decided: Sep 28, 2022 after 47 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: 5 generations back to K091431 (2009). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180861: Vinyl Examination Glove (Clear, Non-Colored), Zhicheng Trading Co., Ltd. (2018) Summary page 4.

## Indications for use
The DISPOSABLE VINYL EXAMINATION GLOVE (Pink, Black, Blue) is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.

Source page: https://510kreport.com/device/K222442
Methodology: https://510kreport.com/methodology