R&G Seguridad E Higiene Industrial S.A.C.

R&G Seguridad E Higiene Industrial S.A.C. specializes in surgical masks, which are intended for use in medical and healthcare environments. These masks are designed to provide a barrier against airborne particles and pathogens, helping to reduce infection risks during procedures.

The company is headquartered in the United States. This location allows it to operate within the regulatory framework of the FDA, which governs medical device authorization in the country.

The company’s devices, such as surgical masks, are classified as Class II medical devices. This classification is determined by the FDA based on factors like the risk associated with the device’s use and its intended purpose, requiring compliance with specific regulatory controls to ensure safety and effectiveness.

Yes, the company’s devices are listed under the FDA’s 510(k) pathway. This pathway is used for medical devices that are not new but are substantially equivalent to legally marketed devices, allowing the manufacturer to demonstrate compliance with regulatory requirements through a pre-market submission process.