PQM FreedomAIRTM Face Masks use imported materials and production processes that are designed to meet American Standards, however, we have not been officially recognised by the FDA and NIOSH agencies. This mask is graded as a Non-Medical Use – Civilian Grade Mask. The American People can not wait for a product like this to hit the market so we are releasing an early design of our product to the public while we obtain the highest certifications. You will have the benefit of accessing these high performance masks as production starts.