# K210463: Thermoplastic Elastomer (TPE) Hybrid Examination Glove

- Pathway: 510(k) (Traditional)
- Applicant: Xuzhou Full Sun Medical Products, Ltd.
- Decided: Jan 23, 2022 after 341 days
- Product code: LZA (Polymer 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 K143247 (2015). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190942: Disposable Powder Free Nitrile Examination Glove, Pink/Black Color, Ever Growth (Vietnam) Co., Ltd. (2020) Summary page 4.

## Most influential descendants
- K222531: Synthetic Polymer Glove - Polyethylene (Black) (2023), 0 descendants of its own

## Indications for use
A patient examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner.

Source page: https://510kreport.com/device/K210463
Methodology: https://510kreport.com/methodology