P.T. Daifatex Indah

P.T. Daifatex Indah specializes in manufacturing latex patient examination gloves, which are intended for single-use medical procedures requiring barrier protection. These gloves are designed to prevent contamination between healthcare providers and patients during examinations or treatments.

P.T. Daifatex Indah is based in the United States, which means its devices are subject to FDA regulations. Since the company’s products fall under Class I classification, they are generally considered low-risk and may be eligible for listing via the 510(k) pathway, though individual device authorisation depends on compliance with FDA requirements.

P.T. Daifatex Indah’s devices are listed in the FDA’s 510(k) registry, which tracks Class I medical devices that have undergone the required premarket notification process. This registry helps ensure transparency and compliance with FDA regulations for these products.

P.T. Daifatex Indah’s latex patient examination gloves are classified as Class I devices by the FDA. This classification is based on their intended use—providing a barrier during medical examinations—and their low-risk profile, which allows for streamlined regulatory oversight compared to higher-risk devices.