Asset Ent., Sdn Bhd

Asset Ent., Sdn Bhd specializes in manufacturing latex patient examination gloves, which are designed for clinical use to provide a barrier during medical procedures. These gloves are intended to protect both patients and healthcare providers from contamination or exposure during examinations and treatments.

Asset Ent., Sdn Bhd is headquartered in the United States. While the company operates there, its devices are regulated under the U.S. Food and Drug Administration (FDA) framework, specifically listed in the 510(k) registry.

The company’s latex patient examination gloves fall under FDA Class I medical devices. This classification is typically assigned to devices posing minimal risk to patients, where general controls (such as good manufacturing practices) are sufficient for safety and effectiveness. The classification is based on the device’s intended use and risk profile.

Yes, the company’s latex patient examination gloves are included in the FDA’s 510(k) registry. This registry tracks devices that have undergone a pre-market notification process to demonstrate substantial equivalence to a legally marketed predicate device, ensuring compliance with U.S. regulatory requirements.