# K180260: Powder Free Vinyl Patient Examination Gloves (Yellow, White)

- Pathway: 510(k) (Traditional)
- Applicant: Shanxi Hongjin Plastic Technology Co., Ltd.
- Decided: Jun 12, 2018 after 133 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 K992861 (1999). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142570: Powder Free Vinyl Patient Examination Gloves ( Yellow, White, BLue, Pink ), Ever Light Plastic Products Co., Ltd. (2014) Summary page 4.

## 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/K180260
Methodology: https://510kreport.com/methodology