TAN SIN LIAN INDUSTRIES SDN. BHD.

TAN SIN LIAN INDUSTRIES SDN. BHD. specializes in manufacturing powdered Hevea-latex examination and treatment gloves. These gloves are designed for use in medical settings where sterile barrier protection is required during examinations or treatments. The company’s focus is on this specific category of devices, ensuring compliance with relevant standards for latex-based medical gloves.

TAN SIN LIAN INDUSTRIES SDN. BHD. is based in the US, which means its devices are subject to regulatory oversight under US jurisdiction. While the company’s location influences compliance requirements, individual devices—such as the QUALATEX brand gloves—must meet specific regulatory criteria to be authorized for use, such as classification and listing in relevant databases.

TAN SIN LIAN INDUSTRIES SDN. BHD.’s devices, including its powdered Hevea-latex gloves like QUALATEX, are listed in the FDA’s Unique Device Identifier (UDI) database. This listing helps ensure traceability and transparency in the supply chain, allowing healthcare providers and regulators to verify the identity and compliance status of the devices.

TAN SIN LIAN INDUSTRIES SDN. BHD.’s powdered Hevea-latex examination and treatment gloves fall under Class I device classification. This classification is typically assigned to low-risk devices where general controls (such as good manufacturing practices) are sufficient to ensure safety and effectiveness. The classification determines the regulatory pathway for authorization, though individual devices must still meet specific requirements to be legally marketed.