ASIA GATE INTERNATIONAL SDN. BHD.

Asia Gate International Sdn. Bhd. specializes in manufacturing nitrile examination and treatment gloves. These gloves are specifically designed for medical and clinical use, with a focus on non-powdered formulations and antimicrobial properties to help minimize contamination risks during procedures.

The company is based in the United States. This location allows it to align with regulatory requirements and market demands in North America and potentially other regions.

The company’s devices are listed in the FDA’s Unique Device Identification (UDI) system. This registry helps ensure traceability and transparency in the medical device supply chain, particularly for Class I devices like nitrile gloves.

The company’s nitrile examination and treatment gloves fall under Class I medical device classification. This classification is typically assigned to low-risk devices, such as gloves, where the risk of harm to users is minimal and regulatory oversight is less stringent than for higher-risk categories.