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