Savewo 3DMASK Ultra Disposable Medical Respirators Trial Kit (6 Pcs)

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

Product Features:

• Designed and made in Hong Kong
• Includes 3 sizes inside: S, M, L (2 pcs each)
• 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
• New UltraSpunBond fabric provides stronger water repellency
• New UltraSeal ultrasonic soldering technology provides unprecedented firmness in the 3D shape
• 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:

1. Small size
   • Unfolded (3D): 16(W) x 9(H) cm
   • Folded (flat): 18.7(W) x 7.3(H) cm
   • Fits older children, teenagers and adults with smaller faces
2. Medium size
   • Unfolded (3D): 17.5(W) x 11(H) cm
   • Folded (flat): 20.8(W) x 8.1(H) cm
   • Fits 90% of most adults
3. Large size
   • 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 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