100% MADE IN CANADA with 100% Canadian made raw materials. The MSL1PM is a 3 layer procedural mask with ear loops intended for use in clinical applications. Mediguard Systems of Canada is a Health Canada registered medical device establishment, we are ISO 13485 compliant, we are authorized for the production and distribution of all Class 1 medical devices, and serve a global client base FLUID RESISTANCE, mmHg 80 BFE â?¥ 95% PFE, @ 0.1 micron â?¥ 95% DELTA P, mm H2O/cm2 < 4.0 FLAME SPREAD CLASS 1 Take advantage of the high level of compliance offered by ASTM standards and the low exchange rate of our Canadian Dollar.