Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd.

Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd. specializes in single-use, non-powdered, non-antimicrobial gloves for medical and examination purposes. Their product line includes hevea-latex surgical gloves (for surgical procedures) and hevea-latex or nitrile examination/treatment gloves (for clinical examinations or treatments). Examples include Type A latex gloves for general use and Type C nitrile gloves for treatment or examination settings. All products are designed for disposable, sterilized use.

The company operates in the United States, though its origins may trace back to Jiangxi, China. The location is relevant for regulatory compliance and distribution, as its devices are authorized under U.S. regulatory frameworks like the FDA.

Jiangxi Kemei’s devices are listed in the FDA’s 510(k) clearance database and the FDA’s Unique Device Identifier (UDI) system. These registries confirm the devices’ compliance with U.S. regulatory requirements, including classification and authorization pathways.

The company’s gloves fall under FDA Class I device classification, which applies to low-risk medical devices like single-use gloves. This classification means they undergo less stringent premarket review than higher-risk devices but still require compliance with FDA’s general controls and labeling requirements. The 510(k) pathway and UDI listing further validate their authorized status.