ASTM Certification is given to products like face masks to determine the level of filtration effectiveness. Masks undergo extensive testing by a trusted third-party laboratory, and assigned one of three ratings:
Level 1 - Unable to filter out microscopic particulate matter (such as viruses), NOT rated for medical use. Level 1 masks are unregulated by agencies like the FDA.
Level 2 - Able to filter out particulate matter of microscopic viruses such as the novel coronavirus. Level 2 masks must be FDA listed to gain approval for medical use. Product CANNOT be called “surgical” without it.
Level 3 - Meets all the requirements necessary for Level 2 certification. Additionally, Level 3 rated masks must pass synthetic blood and fluid penetration testing. Level 3 rated masks must also be FDA-listed for medical use.
(NOTE: Armbrust American Surgical Masks have an ASTM Level 3 certification and are FDA-listed for approved medical use. Learn more HERE)