HSA (SG) Notified Class A Medical Device, License No: ES0501633
Product Features:
- Designed and made in Hong Kong
- One size fits all 3D design
- Type.Cool+ material
- 24+ Hours Effective Filtration – Filtration efficiency maintains 99.9% effectiveness after 24 hours of use at 100% relative humidity
- Patented Anti-Fog Display – Wide transparent window enables visibility of the wearer’s mouth from multiple angles
- VisionFilm – Welded to the centre of the mask with ultrasonic technology, ensuring safety by keeping the mask waterproof and airtight
- Modified from the patented V-Shape design of 3DMASK Extreme Pro with the patented FleXnet support material, to provide a super three-dimensional and firm tailoring, which fits more than 90% of different adult faces
- Adjustable tilt angle of the mask window to enable lip reading for people of different heights
- 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:
- Unfolded (3D): 17.5(W) x 11(H) cm
- Folded (flat): 22(W) x 8.5(H) cm
- Fits 90% of most adults
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
- Conforms with EN149:2001+A1:2009 FFP2 NR (EU) / EN14683:2019 Type IIR (EU) / ASTM F2100-19 Level 3 (US) / KMOEL-2017-64 KF94 (KR)
- 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 / SGS / KOTITI
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