HSA (SG) Notified Class A Medical Device (License No: ES0501633)
Product Features:
- Designed and made in Hong Kong
- Available in regular size
- Stylish 3D design increases breathing space to ensure long-term wearing comfort
- Type.Cool+ material
- 24+ Hours Effective Filtration – Filtration efficiency maintains 99.9% effectiveness after 24 hours of use 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
- 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) / GB2626-2019 KN95 (CN) / JIS T 9001:2021 Class III (JP)
- 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 / SGS / KOTITI
Reviews
There are no reviews yet.