# K180861: Vinyl Examination Glove (Clear, Non-Colored)

- Pathway: 510(k) (Traditional)
- Applicant: Zhicheng Trading Co., Ltd.
- Decided: Jun 13, 2018 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: 4 generations back to K091431 (2009). 4 ancestors in all.
9 later devices descend from it; 6 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K163168: Vinyl Examination Gloves (White), Vinyl Examination Gloves (Blue), Vinyl Examination Gloves (Yellow), Hebei Hongtai Plastic Products Company Limited (2017) Summary page 5.

## Most influential descendants
- K223008: Disposable Vinyl Examination Gloves (2022), 1 descendant of its own
- K220469: Disposable Vinyl Examination Glove (2022), 1 descendant of its own
- K213006: Vinyl Examination Gloves (2021), 1 descendant of its own
- K252505: Powder-Free Vinyl Exam Gloves, clear (2025), 0 descendants of its own
- K241252: Disposable Vinyl Examination Gloves (2024), 0 descendants of its own

## Indications for use
The Vinyl Examination Glove (Clear, Non-Colored) 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/K180861
Methodology: https://510kreport.com/methodology