# K163168: Vinyl Examination Gloves (White), Vinyl Examination Gloves (Blue), Vinyl Examination Gloves (Yellow)

- Pathway: 510(k) (Traditional)
- Applicant: Hebei Hongtai Plastic Products Company Limited
- Decided: Feb 23, 2017 after 101 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: 3 generations back to K091431 (2009). 3 ancestors in all.
30 later devices descend from it; 17 cite it directly.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150224: Blue Vinyl Gloves Powder Free, Zibo Sanying Trade Co., Ltd. (2015) Summary page 5.

## Most influential descendants
- K180861: Vinyl Examination Glove (Clear, Non-Colored) (2018), 9 descendants of its own
- K180849: Vinyl Examination Glove (Clear, Non-Colored) (2018), 4 descendants of its own
- K182043: Single-use medical poly (vinyl chloride) examination glove (Clear, Non-Colored) (2018), 2 descendants of its own
- K223008: Disposable Vinyl Examination Gloves (2022), 1 descendant of its own
- K220469: Disposable Vinyl Examination Glove (2022), 1 descendant of its own

## Indications for use
The Vinyl Examination Gloves (White, Blue, or Yellow) 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/K163168
Methodology: https://510kreport.com/methodology