Specialized nonwoven material structure featuring a 3-ply, pleated construction style to optimize lightness of fit, breathability, and fluid resistance. Manufacturing certified ISO 9001 for quality management systems. Manufacturing certified ISO 13485 for quality management systems for medical devices. FDA 510(k) Approved as a medical device. ASTM F2100 test method for evaluating the performance of level 1 materials used in medical face masks.