Agrimal Industries Sdn. Bhd.

Agrimal Industries Sdn. Bhd. specializes in manufacturing patient latex examination gloves, which are primarily used in medical and clinical settings to provide a barrier between healthcare providers and patients during examinations and procedures. These gloves are designed to ensure hygiene and safety by preventing direct contact with bodily fluids.

The company, Agrimal Industries Sdn. Bhd., is headquartered in the United States. This location is relevant for regulatory compliance, manufacturing operations, and distribution of their medical devices.

Agrimal’s patient latex examination gloves fall under Class I classification according to FDA regulations. Class I devices are generally considered to pose the lowest risk and often require less stringent premarket review, such as a 510(k) submission, to demonstrate substantial equivalence to a legally marketed predicate device.

Yes, Agrimal’s devices are listed in the FDA’s 510(k) registry. This pathway is used for Class I devices to demonstrate that the product is substantially equivalent to a legally marketed predicate device, ensuring compliance with FDA requirements before commercial distribution.