# K211699: Nitrile Exam Gloves, Powder Free, Blue

- Pathway: 510(k) (Traditional)
- Applicant: Hengchang (Dongying) Medical Technology Co., Ltd.
- Decided: Aug 20, 2021 after 78 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Nitrile Exam Gloves, Powder Free, Blue are disposable devices intended for medical purposes that are worn on the examiner’s hands to prevent contamination between patient and examiner.

Source page: https://510kreport.com/device/K211699
Methodology: https://510kreport.com/methodology