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Class II Medical Devices Registration CE Registered (Authorized EU-Representative) Implementation standard EN14683:2019 Rate of bacterial filtration efficiency≧95% Flat, 3-layer The breathing resistance for gas exchange on both sides of the mask should not be greater than 49Pa/cm2. Microbiological indicators: the total number of bacterial colonies of this mask CFU/g≤100; no fungi, E. coli, E. coli, E. coli, Staphylococcus auspicrus, or hemolytic streptococcus.
