# K212840: Nitrile Gloves (Model: NE01)

- Pathway: 510(k) (Traditional)
- Applicant: Byd Auto Industry Company Limited
- Decided: Dec 11, 2021 after 95 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: 4 generations back to K022548 (2002). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203191: LYDUS Nitrile Examination Gloves, Powder Free, Nathan Trading Co., Ltd. (2021) Summary page 5.

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

Source page: https://510kreport.com/device/K212840
Methodology: https://510kreport.com/methodology