P T Perkasa Rubber Industries

P T Perkasa Rubber Industries specializes in manufacturing latex examination gloves. These gloves are intended for medical and clinical use, providing a barrier to protect both healthcare professionals and patients during examinations and procedures.

The company operates from the United States. This location is relevant for regulatory oversight and compliance with local and international medical device regulations.

The latex examination gloves produced by P T Perkasa Rubber Industries are classified as Class I medical devices under FDA regulations. This classification is typically assigned to devices posing minimal risk to users, such as gloves, which are generally considered safe and effective when used as intended. The classification determines the regulatory pathway for market authorization, in this case, the 510(k) pathway, which demonstrates substantial equivalence to a legally marketed predicate device.

The company’s latex examination gloves are listed in the FDA’s 510(k) registry. This registry documents devices that have undergone the 510(k) premarket notification process, demonstrating compliance with FDA requirements for market authorization. Listing here confirms the device’s regulatory status under the specified classification.