Savewo 3DMASK Smile Disposable Medical Respirators (20 Pcs)

HSA (SG) Notified Class A Medical Device, License No: ES0501633

Product Features:

• Designed and made in Hong Kong
• One size fits all 3D design
• 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
• Patented Anti-Fog Display – Wide transparent window enables visibility of the wearer’s mouth from multiple angles
• VisionFilm – Welded to the centre of the mask with ultrasonic technology, ensuring safety by keeping the mask waterproof and airtight
• Modified from the patented V-Shape design of 3DMASK Extreme Pro with the patented FleXnet support material, to provide a super three-dimensional and firm tailoring, which fits more than 90% of different adult faces
• Adjustable tilt angle of the mask window to enable lip reading for people of different heights
• 5mm 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:

• Unfolded (3D): 17.5(W) x 11(H) cm
• Folded (flat): 22(W) x 8.5(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) < 2.4mmH2O (inhalation and exhalation @30L/min)
• Textile Flammability: Class 1
• Passed NIOSH 42 CFR 84 N95 filtration and breathing resistance test
• Conforms with EN149:2001+A1:2009 FFP2 NR (EU) / KMOEL-2017-64 KF94 (KR) / EN14683:2019 Type IIR (EU) / ASTM F2100-19 Level 3 (US)
• 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)
• KFDA Registration Number: 202107925 (KR)
• CE Marking Certification (EU)
• Tested by Nelson Laboratories / SGS / KOTITI / STC