FDA 510(k) Clearance (K210705); >95% BFE and PFE; Synthetic blood penetration 80 mmHg; Differential Pressure < 5 mm H20/cm2; Free from natural rubber latex; Strong malleable nose wire to fit various types of users; Premium ear loops; 3-Ply layers for maximum breathability; Level 2 rated by an independent ISO 17025 accredited testing facility;