# K221983: Biodegradable Powder Free Nitrile Examination Glove, Blue Color, Biodegradable Powder Free Nitrile Examination Glove, Blue Violet Color, Biodegradable Powder Free Nitrile Examination Glove, Green Color

- Pathway: 510(k) (Traditional)
- Applicant: Guangdong Kingfa Sci. & Tech.Co., Ltd.
- Decided: Apr 27, 2023 after 295 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: 2 generations back to K993876 (2000). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162312: Biodegradable Powder Free Nitrile Exam Gloves with Aloe Vera, Green Color, Shen Wei USA, Inc. (2017) Summary page 4.

## Indications for use
The biodegradable nitrile examination glove is intended to be worn on the hands of examiner’s to prevent contamination between patient and examiner. This is a single-use, powder-free, non-sterile device.

Source page: https://510kreport.com/device/K221983
Methodology: https://510kreport.com/methodology