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 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 Disposable Sanitary Face Mask 3-Layers Of Non-Woven Fiber Fabric To Provide Fine Filtration And Maximum Breath-Ability Comfortable To Wear For Hours And Maximize The Protection At The Same Time