Advanced Medical Products Sdn Bhd

Advanced Medical Products Sdn Bhd specializes in manufacturing Dermagrip Ultra powder-free blue nitrile patient examination gloves, which are non-sterile and tested for use with chemotherapy drugs. These gloves are designed to provide barrier protection during medical examinations and procedures.

The company is headquartered in the United States. This location aligns with its regulatory focus on FDA compliance for its medical devices.

The company’s devices, including its Dermagrip Ultra gloves, fall under FDA Class I medical devices. This classification is typically assigned to low-risk products, though clearance via the 510(k) pathway is required to demonstrate compliance with applicable regulations.

Advanced Medical Products Sdn Bhd’s devices are listed in the FDA’s 510(k) clearance database in the United States. This registry confirms that the manufacturer has submitted evidence to demonstrate that their product is substantially equivalent to a legally marketed predicate device.