# K214017: Examination gloves-Type A (Latex gloves)

- Pathway: 510(k) (Traditional)
- Applicant: Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd.
- Decided: Jul 14, 2022 after 204 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: 3 generations back to K152593 (2016). 3 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173053: Powder Free Latex Examination Glove, Professional Latex Sdn Bhd (2018) Summary page 4.

## Most influential descendants
- K222612: Powder-Free Latex examination gloves (2022), 0 descendants of its own
- K222693: Single-use medical latex examination gloves (LG100) (2022), 0 descendants of its own

## Indications for use
The Examination gloves-Type A (Latex gloves) is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Source page: https://510kreport.com/device/K214017
Methodology: https://510kreport.com/methodology