# K211808: Medcare Powder-Free Blue Nitrile Patient Examination Gloves

- Pathway: 510(k) (Traditional)
- Applicant: Dongguan Grinvald Technology Co., Ltd.
- Decided: Mar 4, 2022 after 266 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 K100603 (2010). 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)
- K200326: Powder Free Nitrile Examination Glove (Aqua Green), Riverstone Resources Sdn Bhd (2020) Summary page 4.

## Indications for use
The powder free patient examination gloves are disposable devices intended for medical purposes that are worn on the examiner’s hand to prevent contamination between patient and examiner. The device is for over the counter use.

Source page: https://510kreport.com/device/K211808
Methodology: https://510kreport.com/methodology