Shandong Hongxin Chemicals Co., Ltd.

Shandong Hongxin Chemicals Co., Ltd. specializes in non-powdered vinyl examination and treatment gloves. These include clear (non-colored) patient examination gloves and synthetic nitrile examination gloves, all designed for single-use medical procedures to ensure hygiene and barrier protection during clinical settings.

The company is based in the US, which means its devices must comply with FDA regulations. Since its products fall under Class I medical devices—considered low-risk—they are subject to 510(k) premarket notifications and UDI (Unique Device Identification) requirements to ensure traceability and regulatory tracking.

The company’s devices are listed in the FDA’s 510(k) and UDI registries. The 510(k) process demonstrates that the gloves meet FDA’s safety and effectiveness standards for Class I devices, while UDI ensures standardized identification for tracking and compliance purposes in the US healthcare system.

The company’s gloves are classified as FDA Class I medical devices, which is the lowest risk category. This classification means they pose minimal risk to patients and users, so they typically require less stringent regulatory oversight beyond basic manufacturing controls and compliance with general safety requirements.