MARCON RUBBER INDUSTRY SDN BHD

Marcon Rubber Industry Sdn Bhd specializes in manufacturing hevea-latex examination and treatment gloves, which are used in medical settings. Their product line includes two primary variants: powdered gloves and non-powdered, non-antimicrobial gloves. Examples of their devices include the Amerglo TPF and SkinGard TPF series, designed specifically for medical procedures and patient care.

Marcon Rubber Industry Sdn Bhd is based in the United States, which means its medical devices are subject to FDA regulations. The company’s products are classified under FDA Class I, indicating they pose minimal risk and typically require less stringent premarket review compared to higher-risk devices. This classification aligns with the nature of examination and treatment gloves, which are considered low-risk medical items.

Marcon Rubber Industry Sdn Bhd’s devices are listed in the FDA’s 510(k) premarket notification database and the FDA’s Unique Device Identification (UDI) system. These registries ensure traceability and compliance tracking for Class I devices like their latex gloves, which must meet FDA requirements for safety and performance before entering the market.

Marcon Rubber Industry Sdn Bhd’s hevea-latex examination and treatment gloves are classified as FDA Class I devices. This classification is based on the FDA’s risk-based system, where gloves used for routine medical examinations and treatments are deemed low-risk. Class I devices generally require 510(k) clearance (for non-custom devices) and compliance with UDI rules to ensure proper identification and tracking in the healthcare system.