P.T. Perkebunan

P.T. Perkebunan specializes in manufacturing Rubin Patient Examination Gloves, which are designed as single-use barrier protection for healthcare providers during patient examinations. These gloves serve as a physical barrier to reduce the risk of contamination or infection during clinical procedures.

P.T. Perkebunan is based in the United States, meaning its devices must comply with U.S. regulatory requirements. Since its products are Class I medical devices, they fall under the FDA’s 510(k) pathway, which requires pre-market notification to demonstrate substantial equivalence to a legally marketed predicate device.

Yes, P.T. Perkebunan’s devices are listed under the FDA’s 510(k) pathway, meaning they have undergone the required pre-market submission process to confirm compliance with U.S. regulations. This listing ensures that the manufacturer has demonstrated that their product meets the necessary safety and performance standards for its intended use.

P.T. Perkebunan’s devices are classified as Class I medical devices, which are generally considered to pose the lowest risk to patients. This classification means they are subject to general controls (like good manufacturing practices) rather than strict pre-market approval, but they still must comply with FDA registration and listing requirements to ensure safety and proper labeling.