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The surgical face masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single-use, disposable device, provided non-sterile. Level 2 Face Mask Models: FCY-L2-E, FCY-L2-T Level 3 Face Mask Models: FCY-L3-E, FCY-L3-T

The Proposed device has one size 17.5 cm x 9.5 cm and two wear types of Ear Loops and Tie-On. They are available in blue and white colors and three barrier levels (Level 3) according to ASTM F2100:2019. The proposed Level 2 and Level 3 masks are the same product which can pass ASTM F2100-19 Level 2 & 3 at the same time; they are classified into level 3 just because of the marketing strategies. All the materials of proposed tie-on masks are included in ear loops masks. The outer layer, inner layer, middle melt-blown layer and PET coated iron wire nose clip of tie-on masks are exactly the same with ear-loop masks, the tie tapes of tie-on masks are same as the outer layer of white mask body but 3 layers folded and physically ultrasonic welding together. The proposed mask can form a physical barrier by being worn on the mouth and nose of medical staff to protect both the patient and healthcare personnel from the spread of microorganisms, blood and body fluids, and particulate materials. The proposed subject device, surgical face mask, operates by acting as a physical barrier. The barrier protects the medical staff, patient, and healthcare personnel from the spread of microorganisms, blood and body fluids, and particulate materials. The barrier goes over the mouth and nose of the user.