HSA (SG) Notified Class A Medical Device, License No: ES0501633
Product Features:
- Designed and made in Hong Kong
- Available in 4 different colours: Darksoul Black, Castle Grey, Forest Green, Deepsea Blue
- Medium size: 20.8 x 8.1cm (closed), 17.5 x 11 cm (opened), 17cm long ear loops
- Large size: 22 x 8.6cm (closed), 18.5 x 12 cm (opened), 18cm long ear loops
- Stylish 3D design increases breathing space to ensure long-term wearing comfort
- TypeCool+ material
- New UltraSpunBond fabric provides stronger water repellency
- New UltraSeal ultrasonic soldering technology provides unprecedented firmness in the 3D shape
- 24+ Hours Effective Filtration: Filtration efficiency decreases by just 0.1% after 24 hours of use at 100% relative humidity
- 3mm wide comfortable ear loops
- Latex-free and anti-allergic
- Smooth ESPP inner layer is gentle on skin
- Manufactured with the safest colour pigments
- Does not contain 212 types of Substance of Very High Concern (SVHC)
- Does not contain azo dyes in textile
- Individual packaging
Certifications & Tests Passed:
- Bacterial Filtration Efficiency (BFE) > 99.9%
- Particle Filtration Efficiency (PFE) > 99.9% @0.1µm
- Viral Filtration Efficiency (VFE) > 99.9%
- Delta-P (breathing resistance) < 2.4
- Fluid resistance of 160mmHg
- Textile Flammability: Class I
- EN149:2001+A1:2009 FFP2 (EU)
- KMOEL-2017-64 KF94 (KR)
- Niosh 42 CFR 84 N95 (US)
- ASTM F2100-19 Level 3 (US)
- EN14683:2019 Type IIR (EU)
- Passed Minimal Essential Media (MEM) Elution Test
- Passed Microbiological Cleanliness (Bioburden) Test
- ISO 14644-1:1999 Class 7 Cleanroom
- ISO13485:2016 Medical Devices – Quality Management Systems
- CE Marking Certification (EU)
- FDA Registration Number: 3017178899 (US)
- Passed KF Mask Test KF94 (KR)
- Passed STC 24 Hours Filtration Efficiency Test (HK)
- Tested by Nelson Laboratories/SGS/KOTITI
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