Savewo 3DBEAR Disposable Medical Masks for Babies – Pink (30 Pcs)

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

Product Features:

• Designed and made in Hong Kong
• Available in 3 different colours: White, Blue, Pink
• Patented 3D Bear design for babies
• Type.Cool+ material
• 24+ Hours Effective Filtration – Filtration efficiency maintains 99.9% effectiveness after 24 hours of use at 100% relative humidity
• Strip-free and well-sealed design is gentle and protective
• 6mm wide comfortable ear loops – Made with a soft and ultra-elastic fabric material, ensuring maximum comfort for long hours
• 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
• Antimicrobial inner ESPP layer prevents bacterial growth inside the mask due to the accumulation of saliva and mucus
• Individual packaging

Size:

• Unfolded (3D): 10(W) x 8.5(H) cm
• Folded (flat): 6.8(W) x 10(H) cm
• Suitable for infants and toddlers aged 6-24 months

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 @120mmHg of pressure
• Breathing Resistance (Delta-P) < 2.8mmH2O (inhalation and exhalation @30L/min)
• Conforms with EN14683:2019 Type IIR (EU) / ASTM F2100-19 Level 2 (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)
• CE Marking Certification (EU)
• Tested by Nelson Laboratories