HSA Notified Class A Medical Device (License No: ES0501633)
Product Features:
- Designed and made in Hong Kong
- Available in 4 sizes: S, R, M, L
- Innovative TypeCool+ filtration technology with ultra-high breathability
- 24+ Hours Effective Filtration – Filtration efficiency maintains 99.9% effectiveness after 24 hours of exposure at 100% relative humidity
- New UltraSpunBond fabric provides stronger water repellency
- New UltraSeal ultrasonic soldering technology provides unprecedented firmness in the 3D shape
- 5mm wide comfortable ear loops
- Latex-free and anti-allergic
- ESPP Non-Woven Fabric – Smooth hydrophilic ESPP inner layer effectively maintains the ideal level of humidity inside the mask and prevents excessive loss of moisture from your skin
- Individual packaging
Size:
- Small size (S)
- Unfolded (3D): 16(W) x 9(H) cm
- Folded (flat): 18.7(W) x 7.3(H) cm
- Fits older children, teenagers and adults with smaller faces
- Regular size (R)
- Unfolded (3D): 17(W) x 11(H) cm
- Folded (flat): 20.8(W) x 8.1(H) cm
- Fits 90% of most adults (slim fit)
- Medium size (M)
- Unfolded (3D): 17.5(W) x 11(H) cm
- Folded (flat): 20.8(W) x 8.1(H) cm
- Fits 90% of most adults
- Large size (L)
- Unfolded (3D): 18.5(W) x 12(H) cm
- Folded (flat): 22(W) x 8.6(H) cm
- Fits adults with larger faces
Certifications & Tests Passed:
- Bacterial Filtration Efficiency (BFE) ≥ 99.9%
- Particle Filtration Efficiency (PFE) ≥ 99.9% @0.1µm
- Viral Filtration Efficiency (VFE) ≥ 99.9%
- Fluid Resistance: Resists synthetic blood @160mmHg of pressure
- Breathing Resistance (Delta-P) < 2.4mmH2O (inhalation and exhalation @30L/min)
- Textile Flammability: Class 1
- Passed NIOSH 42 CFR 84 N95 filtration and breathing resistance test
- Conforms with EN149:2001+A1:2009 FFP2 NR (EU) / KMOEL-2017-64 KF94 (KR) / ASTM F2100-19 Level 3 (US) / 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)
- KFDA Registration Number: 202107925 (KR)
- CE Marking Certification (EU)
- Tested by Nelson Laboratories / SGS / KOTITI / STC
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