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
- 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
- UltraSpunBond fabric provides stronger water repellency and is capable of resisting droplets and splashes at a pressure of 160 mmHg
- Patented 3D design fits better to your nose bridge and your face shape in order to prevent not only inward leakage but also fogging for glasses wearers
- UltraSeal welding technology creates a firmer and more durable three-dimensional structure
- 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
- Colour masterbatch technology with the highest safety level
- Does not contain 212 types of Substance of Very High Concern (SVHC)
- Does not contain azo dyes in textile
- Does not contain fluorescein
- Individual packaging
Size:
- 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 I
- Passed NIOSH 42 CFR 84 N95 filtration and breathing resistance test
- Conforms with KMOEL-2017-64 KF94 (KR) / ASTM F2100-19 Level 3 (US) / EN14683:2019 Type IIR (EU) / JIS T 9001:2021 Class III (JP)
- Passed Minimal Essential Media (MEM) Elution Test
- Passed ISO10993-10 Skin Irritation and Sensitisation Test
- Passed Microbiological Cleanliness (Bioburden) Test
- ISO9001:2015 Quality Management System
- ISO13485:2016 Medical Devices – Quality Management Systems
- ISO14001:2015 Environmental Management System
- 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 / KOTITI / STC
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