# K212899: Disposable Vinyl/Nitrile Blend Medical Examination Gloves

- Pathway: 510(k) (Traditional)
- Applicant: Bytech (Dongtai) Co., Ltd.
- Decided: Dec 11, 2021 after 89 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 K051662 (2005). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211262: Disposable Vinyl Nitrile Synthetic Gloves Powder Free, Tangshan Hongyun Healthcare Products Co., Ltd. (2021) Summary page 4.

## Indications for use
The Disposable Vinyl/Nitrile Blend Medical Examination Gloves is intended for medical purposes that is worn on the examiners hands to prevent contamination between patient and examiner.

Source page: https://510kreport.com/device/K212899
Methodology: https://510kreport.com/methodology