HSA Notified Class A Medical Device (License No: ES501633)
Product Features:
- Designed and made in Hong Kong
- 5 colours ear loops inside: Blueberry (blue), Green tea (green), Grape (purple), Lemon (yellow), Strawberry (pink)
- Size: 20.8 x 8.1 cm (closed), 17 x 11 cm (opened), 17cm long ear loops
- Stylish 3D design increases breathing space to ensure long-term wearing comfort
- Innovative TypeCool+ filtration technology with ultra-high breathability
- 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
- 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
- Passed NIOSH 42 CFR 84 N95 filtration and breathing resistance test
- Conforms with ASTM F2100-19 Level 3 (US) / KMOEL-2017-64 KF94 (KR) / EN14683:2019 Type IIR (EU)
- Passed Minimal Essential Media (MEM) Elution Test
- Passed Microbiological Cleanliness (Bioburden) Test
- ISO13485:2016 Medical Devices – Quality Management Systems
- ISO 14644-1:1999 Class 7 Cleanroom
- FDA Registration Number: 3017178899 (US)
- CE Marking Certification (EU)
- Tested by Nelson Laboratories / KOTITI
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