Comfortable to Wear for Hours and Maximize the Protection at the Same Time. 3-Layers of Non-Woven Fiber Fabric to Provide Fine Filtration and Maximum Breath-ability. Disposable Sanitary Face Mask. These are class 1 medical devices that are exempt from the FDA’s 501(k) reporting requirements. These products manufactured by an FDA registered manufacturer. These masks are class 1 medical devices, and can be used for healthcare use, but should not be used in surgical or high-risk situations, or where there is a high risk of contact with liquids or infectious materials.