# K222612: Powder-Free Latex examination gloves

- Pathway: 510(k) (Traditional)
- Applicant: Guangdong Kingfa Sci. & Tech.Co., Ltd.
- Decided: Nov 25, 2022 after 87 days
- Product code: LYY (Latex 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 K152593 (2016). 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)
- K214017: Examination gloves-Type A (Latex gloves), Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd. (2022) Summary page 4.

## Indications for use
The powder-free patient examination glove is a disposable device intended for medical purposes that is worn on the examiner’s hand or finger or finger to prevent contamination between patient and examiner.

Source page: https://510kreport.com/device/K222612
Methodology: https://510kreport.com/methodology