# K210578: Medical Nitrile Examination Gloves (Power free, Blue)

- Pathway: 510(k) (Traditional)
- Applicant: Jiangxi Hongda Medical Equipment Group, Ltd.
- Decided: Jul 10, 2021 after 134 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: 5 generations back to K993247 (1999). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150340: POWDER FREE Nitrile GLOVES (White), POWDER FREE Nitrile GLOVES (Cobalt Blue), POWDER FREE Nitrile GLOVES (Black), POWDER FREE Nitrile GLOVES (Ice Blue), Hebei Hongsen Plastics Technology Co, Ltd. (2015) Summary page 4.

## Indications for use
The Medical Nitrile Examination Gloves (Powder free, Blue) is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.

Source page: https://510kreport.com/device/K210578
Methodology: https://510kreport.com/methodology