# K180381: Powder Free Vinyl Patient Examination Gloves

- Pathway: 510(k) (Traditional)
- Applicant: Shanxi Hongjin Plastic Technology Co., Ltd.
- Decided: Nov 7, 2018 after 268 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: 2 generations back to K060778 (2006). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142571: Powder Free Vinyl Patient Examination Gloves, Ever Light Plastic Products Co., Ltd. (2014) Summary page 4.

## Most influential descendants
- K211177: Powder Free Vinyl Patient Examination Gloves (2021), 0 descendants of its own

## Indications for use
A patient examination glove is disposable non-sterile device intended for medical purpose that is worn on the examiner’s hand or finger to prevent contamination between patient and examiner.

Source page: https://510kreport.com/device/K180381
Methodology: https://510kreport.com/methodology