# K180849: Vinyl Examination Glove (Clear, Non-Colored)

- Pathway: 510(k) (Traditional)
- Applicant: Huifu Trading Co., Ltd.
- Decided: Jun 11, 2018 after 70 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.
4 later devices descend from it; 2 cite it directly.
0 of 9 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
- K182043: Single-use medical poly (vinyl chloride) examination glove (Clear, Non-Colored) (2018), 2 descendants of its own
- K211229: Vinyl compound examination gloves (2021), 0 descendants of its own
- K210821: Medical PVC Examination Gloves (2021), 0 descendants of its own
- K201504: Single-use medical poly (vinyl chloride) examination glove (2021), 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/K180849
Methodology: https://510kreport.com/methodology