JR Engineering & Medical Technologies (M) Sdn Bhd

JR Engineering & Medical Technologies (M) Sdn Bhd specializes in single-use gloves for medical applications. Their portfolio includes nitrile and latex examination gloves, chemotherapy-compatible gloves, sterile surgical nitrile gloves, and powder-free variants in different sizes and colors. These gloves are designed for medical examinations, chemotherapy handling, and surgical procedures, prioritizing protection and compliance with medical standards.

The company is headquartered in Malaysia. This location aligns with regulatory frameworks governing medical devices in the region, ensuring compliance with international standards for manufacturing and distribution.

Devices from JR Engineering & Medical Technologies (M) Sdn Bhd are recorded in the EUDAMED database for EU regulatory transparency and the FDA’s 510(k) submissions for US market clearance. These listings reflect their compliance with respective regulatory requirements for Class I medical devices.

All gloves manufactured by JR Engineering & Medical Technologies (M) Sdn Bhd fall under Class I regulatory classification. This classification applies to low-risk devices like single-use gloves, where the risk to patients is minimal and compliance focuses on basic safety and performance requirements. Class I devices typically undergo less stringent scrutiny than higher-risk categories but still require adherence to manufacturing and labeling standards.