【Mask X Products Specification】
Disposable Surgical Face Mask - 3PLY
Bacterial Filtration Efficiency BFE ≥99%
Particle Filtration Efficiency PFE ≥99%
Viral Filtration Efficiency VFE ≥99%
Breathing Resistance <3.6mm H₂O/cm²
Fluid Penetration Resistance 160mmHg
Passed EN ISO 11737-1:2018 Microbial Cleanliness (Bioburden) Test
Conforms with ASTM F2100-20 Level 3 (US) standards.
Conforms with EN14683:2019 Type IIR (EU) standards.
Regulated by FDA (US) Registration Number: 3017310867
ISO13485:2016 Medical Devices Quality Management System
ISO14644-1:2015 Class7 cleanroom production