Bacterial Filtration Efficiency (BFE) ≥ 99.9%
Particle Filtration Efficiency (PFE) ≥ 99.9% @0.1µm
Viral Filtration Efficiency (VFE) ≥ 99.9%
Fluid Resistance: Resists synthetic blood @ 160mmHg of pressure
Ultra-Low Breathing Resistance <2.4mmH2O @30L/min
Passed NIOSH 42 CFR 84 N95 (US) filtration and breathing resistance test
Conforms with ASTM F2100-19 Level 3 (US) / EN14683:2019 Type IIR (EU) / KMOEL-2017-64 KF94 (KR) / GB2626-2019 KN95 (CN) / JIS T 9001:2021 Class III (JP) (Tested by KAKEN)
Passed ISO10993-5 MEM Elution Test and ISO10993-10 Skin Irritation and Sensitisation Test, Biocompatibility of medical devices
ISO9001:2015 Quality Management System
ISO13485:2016 Medical Devices Quality Management System
ISO14001:2015 Environmental Management System
ISO14644-1:2015 Class 7 Cleanroom
Regulated by FDA (US), Registration Number: 3017178899
Regulated by MFDS (KFDA) (KR), Registration Number: 202107925
Tested by Nelson Laboratories / KOTITI / STC