# K153028: Synmax Synthetic Patient Examination Vinyl Gloves, Powder Free, Blue

- Pathway: 510(k) (Traditional)
- Applicant: Zibo Huiying Medical Products, Co., Ltd.
- Decided: Feb 5, 2016 after 112 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: 1 generation back to K051662 (2005). 1 ancestor in all.
10 later devices descend from it; 9 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051662: Vinyl Nitrile CO-Polymer Powder Free Exam Gloves (Blue Color), Grand Work Plastic Products Co., Ltd. (2005) Summary page 4.

## Most influential descendants
- K211262: Disposable Vinyl Nitrile Synthetic Gloves Powder Free (2021), 1 descendant of its own
- K213634: Vinyl/Nitrile Blend Exam Glove (2022), 0 descendants of its own
- K212436: NBR Synthetic Nitrile Examination Gloves (2021), 0 descendants of its own
- K212899: Disposable Vinyl/Nitrile Blend Medical Examination Gloves (2021), 0 descendants of its own
- K212488: Synthetic Nitrile Examination Gloves (2021), 0 descendants of its own

## Indications for use
A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner’s hands or fingers to prevent contamination between patient and examiner.

Source page: https://510kreport.com/device/K153028
Methodology: https://510kreport.com/methodology