100% MADE IN CANADA with 100% Canadian made raw materials. The MSL2PM 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 - 120 BFE - 98% PFE, @ 0.1 micron - 98% DELTA P, mm H2O/cm2 - < 5.0 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.