EN149:2001 + A1:2009 FFP2 (EU) Respirator Standards

3+

KMOEL-2017-64 KF94 (Korea) standard

GB2626-2019 KN95 (CN) standard

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%

2+

ASTM F2100-20 Level 3 (US) / EN14683:2019 Type IIR (EU) - Accelerated Aging Test as per ASTM F1980-16 (3 years)

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

Certificate of Free Sales, Korea

EU Declaration of Comformity

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

EN149:2001 + A1:2009 FFP2 (EU) Respirator standards

KMOEL-2017-64 KF94 (Korea) standard

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

Module B: EU Type Examination / EN149:2001+A1:2009
FFP2 respirator standards

EN149:2001 + A1:2009 FFP2 (EU) Respirator Standards

KMOEL-2017-64 KF94 (Korea) standard

GB2626-2019 KN95 (CN) standard

6+

ASTM F2100-19 Level 3 (US) standards/
EN14683:2019 Type IIR (EU) standards

TYPECOOL+ technology

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

KMOEL-2017-64 KF94 (Korea) standard

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

ASTM F2100-19 Level 3 (US) standards

EN14683:2019 Type IIR (EU) standards

TYPECOOL+ technology

4+

FDA (US) Class II medical device 510(k)

6+

ASTM F2100-19 Level 3 (US) standards

EN14683:2019 Type IIR (EU) standards

TYPECOOL+ technology

ISO10993-5 MEM Elution Test, Biocompatibility of medical devices

4+

ISO10993-10 Skin Irritation and Sensitization Test, Biocompatibility of medical devices

SARS-CoV-2 Test
EN14476:2019 (with modification), 3g salt/ 300ml water, mode 2 (10s)

General Purpose
EN1276:2019, 3g salt/ 300ml water, mode 2 (10s)

Hand Hygiene
EN1276:2019, 3g salt/ 300ml water, mode 2 (10s)

Hypochlorite content, 1g salt/ 300ml water, mode 1-2 (3-5mins)

Active Chlorine Content, 0-30 days

Hypochlorite content, tap water, 3g salt/ 300ml water, mode 1-2 (3-5mins)

XRF Screening and Chemical Confirmation Test Report

EMC Directive 2014/30/EU (IEC)

Hypochlorite content 2g salt/ 200ml tap water, mode Low, Middle & High (3-5mins)

IPX6 Waterproof Test Report IEC 60529:2013

UVR Transmission of Dry Textile, Light Blocking, Spray Test

Airborne coronavirus (HCoV-229E) filtration rate (60mins)

Airborne particle and bacteria filtration rate (60mins)

Certification of Electromagnetic Compatibility (EMC) Testing

Certification of Conformity EC Council Directive 2014/53/EU of Radio Equipment (IEC)

Electrical Appliance and Material Safety Law – Other Electrical Appliances and Materials – Electric Motor-operated Appliances – Electric air cleaners (PSE 日本專用型號)

Passed Compliance Test - European Parliament and Council Directive 2011/65/EU on the Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment (RoHS) with its Amendments (EU) 2015/863