HSA (SG) Notified Class A Medical Device, License No: ES0501633 BBD for Clearance Products: 09/12/24 Product Features: Designed and made in Hong Kong Available in 2 designs: Hello Kitty Post, Super Duper Hello Kitty Day 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
