As a surgical mask, GIKO 1400 is classified as Class II Medical Device under Regulation 21 CFR 878.4040. It is intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids and particulate material. It has an. elastic rubber headband which keeps its strength even after long time use. The inside of the nose piece utilizes a closed cell foam and the outside nose piece which conforms to the nose is made of plastic coated aluminum.