# K150224: Blue Vinyl Gloves Powder Free

- Pathway: 510(k) (Traditional)
- Applicant: Zibo Sanying Trade Co., Ltd.
- Decided: May 12, 2015 after 99 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 K091431 (2009). 2 ancestors in all.
33 later devices descend from it; 3 cite it directly.
0 of 36 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142508: Powder Free Yellow Vinyl Patient Examination Gloves, Zibo Huaqi Trading Co., Ltd. (2014) Summary page 6.

## Most influential descendants
- K163168: Vinyl Examination Gloves (White), Vinyl Examination Gloves (Blue), Vinyl Examination Gloves (Yellow) (2017), 30 descendants of its own
- 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

## Indications for use
The BLUE VINYL EXAMINATION GLOVES POWDER FREE is a disposable device intended for medical purposes that is worn on the examiner’s hands or finger to prevent contamination between patient and examiner.

Source page: https://510kreport.com/device/K150224
Methodology: https://510kreport.com/methodology