SANIAID® surgical masks are BFE tested by Nelson Labs and have all passed Type II and Type IIR based on EN14683:2019. We are in close contact with Nelson Labs. For ASTM requirements, the standard has been harmonized with EN testing, hence PFE is guaranteed. Our production floor in Japan has provided necessary samples for additional PFE testing. The factory has been producing masks since 1960 and we are more than confident to pass both, ASTM and EN standards. NIOSH is tested and approved for our N95 type respirator which we will launch shortly.
We take quality extremely seriously and are fully transparent in our efforts to ensure a high-quality level. You may want to refer to the publication from Nelson Labs.
