P.T. Multi Latexindo

P.T. Multi Latexindo specializes in manufacturing patient examination gloves made from latex. These gloves are designed for single-use in medical procedures and examinations, serving as a protective barrier against pathogens and contaminants during clinical interactions.

P.T. Multi Latexindo operates from the United States, where it must comply with domestic regulatory requirements for its medical devices. While the company’s location influences the applicable laws and standards it follows, individual devices—like its latex examination gloves—must meet specific regulatory criteria (e.g., FDA classification and clearance pathways) to be legally marketed.

P.T. Multi Latexindo’s latex examination gloves are classified as Class I medical devices under FDA regulations. This classification is determined by the device’s risk level: Class I devices are generally considered low-risk and often subject to 510(k) premarket notification requirements. The classification matters because it dictates the regulatory pathway for authorization, ensuring the device meets safety and performance standards before entering the market.

P.T. Multi Latexindo’s devices, including its latex examination gloves, are listed in the FDA’s 510(k) database. This registry confirms that the manufacturer has submitted a 510(k) premarket notification, demonstrating that their device is substantially equivalent to a legally marketed predicate device and complies with applicable FDA requirements.