CERTIFICATES & TESTING REPORTS
These are only parts of our reports, please do not hesitate to contact us for any enquiries.
Product Certification
KMOEL-2017-64 KF94 (Korea) Respirator Standards
2+
NIOSH 42 CFR 84 N95 (US) Filtration and Breathing Resistance Test
7+
ASTM F2100-19 Level 3 (US) standards/
EN14683:2019 Type IIR (EU) standards/
VFE ≥99.9%
JIS T 9001:2021 Class III, BFF/PFE/VFE and more.. Japanese medical face masks standard (by KAKEN)
ISO10993-5 MEM Elution Test, Biocompatibility of medical devices
2+
ISO10993-10 Skin Irritation and Sensitization Test, Biocompatibility of medical devices
TYPECOOL+ technology
*As proven by professional laboratory tests, the filtration efficiency is maintained at an astonishing 99.9% upon exposure to 100% relative humidity for 24 hours.
3DMASK KIDS
ASTM F2100-19 Level 3 (US) standards
3DMASK KIDS
EN149:2001+A1:2009
Breathing Resistance
3DMASK KIDS
EN14683:2019 Type IIR (EU) standards
EN149:2001 + A1:2009 FFP2 (EU) Respirator Standards
3+
KMOEL-2017-64 KF94 (Korea) Respirator Standards
2+
NIOSH 42 CFR 84 N95 (US) Filtration and Breathing Resistance Test
7+
ASTM F2100-19 Level 3 (US) standards/
EN14683:2019 Type IIR (EU) standards/
VFE ≥99.9%
COVID-19 Medical Device Class I, Health Canada
ISO10993-5 MEM Elution Test, Biocompatibility of medical devices
2+
ISO10993-10 Skin Irritation and Sensitization Test, Biocompatibility of medical devices
TYPECOOL+ technology
*As proven by professional laboratory tests, the filtration efficiency is maintained at an astonishing 99.9% upon exposure to 100% relative humidity for 24 hours.
EN149:2001 + A1:2009 FFP3 (EU) Respirator Standards
KMOEL-2017-64 KF99 (Korea) Respirator Standards
ASTM F2100-19 Level 3 (US) standards/
EN14683:2019 Type IIR (EU) standards
COVID-19 Medical Device Class I, Health Canada
VFE at an Increased Challenge Level 99.99%
ISO14362-1:2017 Azo Dyes Test
ISO10993-5 MEM Elution Test, Biocompatibility of medical devices
2+
ISO10993-10 Skin Irritation and Sensitization Test, Biocompatibility of medical devices
TYPECOOL+EX technology
*As proven by professional laboratory tests, the filtration efficiency is maintained at an astonishing 99.9% upon exposure to 100% relative humidity for 24 hours.
EN149:2001 + A1:2009 FFP2 (EU) Respirator standards
KMOEL-2017-64 KF94 (Korea) Respirator Standards
2+
NIOSH 42 CFR 84 N95 (US) Filtration and Breathing Resistance Test
ASTM F2100-19 Level 3 (US) Standards
EN14683:2019 Type IIR (EU) Standards
ISO10993-5 MEM Elution Test, Biocompatibility of medical devices
2+
ISO10993-10 Skin Irritation and Sensitization Test, Biocompatibility of medical devices
TYPECOOL+ technology
*As proven by professional laboratory tests, the filtration efficiency is maintained at an astonishing 99.9% upon exposure to 100% relative humidity for 24 hours.
ASTM F2100-19 Level 3 (US) standards
EN14683:2019 Type IIR (EU) standards
COVID-19 Medical Device Class I, Health Canada
JIS T 9001:2021 Class III, BFF/PFE/VFE and more.. Japanese medical face masks standard (by KAKEN)
TYPECOOL+ technology
*As proven by professional laboratory tests, the filtration efficiency is maintained at an astonishing 99.9% upon exposure to 100% relative humidity for 24 hours.
ASTM F2100-19 Level 3 (US) standards
EN14683:2019 Type IIR (EU) standards
JIS T 9001:2021 Class III, BFF/PFE/VFE and more.. Japanese medical face masks standard (by KAKEN)
TYPECOOL+ technology
*As proven by professional laboratory tests, the filtration efficiency is maintained at an astonishing 99.9% upon exposure to 100% relative humidity for 24 hours.
ASTM F2100-19 Level 3 (US) standards
EN14683:2019 Type IIR (EU) standards
TYPECOOL+ technology
*As proven by professional laboratory tests, the filtration efficiency is maintained at an astonishing 99.9% upon exposure to 100% relative humidity for 24 hours.
6+
ASTM F2100-19 Level 3 (US) standards
EN14683:2019 Type IIR (EU) standards
TYPECOOL+ technology
*As proven by professional laboratory tests, the filtration efficiency is maintained at an astonishing 99.9% upon exposure to 100% relative humidity for 24 hours.
ISO10993-5 MEM Elution Test, Biocompatibility of medical devices
4+
ISO10993-10 Skin Irritation and Sensitization Test, Biocompatibility of medical devices
Factory Certification
ISO 9001:2015 Quality Management System
ISO 13485:2016 Medical Devices Quality Management System
ISO 14001:2015 Environmental Management System
ISO 14644-1:2015 Class7 Cleanroom
Facility and Merchandise Authorization (FAMA) (By Disney)
Material Certification
2+
TYPECOOL+ / TYPECOOL+ EX technology
*As proven by professional laboratory tests, the filtration efficiency is maintained at an astonishing 99.9% upon exposure to 100% relative humidity for 24 hours.
2+
ISO10993-5 MEM Elution Test, Biocompatibility of medical devices
8+
ISO10993-10 Skin Irritation and Sensitization Test, Biocompatibility of medical devices
JIS T 9001:2021 Class III
特定芳香族アミンの検出
Japanese medical face masks standard (by KAKEN)
JIS T 9001:2021 Class III
遊離ホルムアルデヒド量
Japanese medical face masks standard (by KAKEN)
Certification - Medical and Health Bureau
3+
CE Marking Certification (EU)
Regulated by FDA (US)
Regulated by MFDS (KFDA) (Korea)
3+
COVID-19 Medical Device Class I, Health Canada
Module B: EU Type Examination / EN149:2001+A1:2009
FFP3 respirator standards
Module B: EU Type Examination / EN149:2001+A1:2009
FFP2 respirator standards