HSA (SG) Notified Class A Medical Device, License No: ES0501633
Product Features:
- Designed and made in Hong Kong
- 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
- 6mm 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
- 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
Size:
- Dimensions: 17.5(W) x 9.5(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) < 3.4mmH2O (inhalation and exhalation @30L/min)
- Textile Flammability: Class I
- Conforms with 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)
- CE Marking Certification (EU)
- Tested by Nelson Laboratories / STC
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