HSA (SG) Notified Class A Medical Device, License No: ES0501633
Product Features:
- Designed and made in Hong Kong
- Available in 4 different colours: Dusty Rose (Dark Pink), Lilac (Purple), Night Sea (Blue), Hojicha (Brown)
- 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
- 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
- Does not contain fluorescein
- Individual packaging
Size:
- Regular Size
- Unfolded (3D): 17(W) x 11(H) cm
- Folded (flat): 20.8(W) x 8.1(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
- Ultra-Low Breathing Resistance <2.4mmH2O (inhalation and exhalation @30l/min)
- Textile Flammability: Class I
- Passed NIOSH 42 CFR 84 N95 (US) filtration and breathing resistance test
- Conforms with ASTM F2100-19 Level 3 (US) / EN14683:2019 Type IIR (EU) / KMOEL-2017-64 KF94 (KR)
- Passed ISO10993-5 MEM Elution Test and ISO10993-10 Skin Irritation and Sensitisation Test, Biocompatibility of medical devices
- ISO9001:2015 Quality Management System
- ISO13485:2016 Medical Devices Quality Management System
- ISO14001:2015 Environmental Management System
- ISO14644-1:2015 Class 7 Cleanroom
- Regulated by FDA (US), Registration Number: 3017178899
- Regulated by MFDS (KFDA) (KR), Registration Number: 202107925
- CE Marking Certification (EU)
- Tested by Nelson Laboratories / KOTITI / STC
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