SAVEWO 3DMASK ULTRA - TYPECOOL+ 「FFP2 + KF94 + ASTM LEVEL3 certified 」(30 pieces individually packaged/Box)

FDA Registration Number: 3017178899 (US)

PACKAGE INCLUDED: 

SAVEWO 3DMASK ULTRA - TYPECOOL+ 「FFP2 + KF94 + ASTM LEVEL3 certified 」(30 pieces individually packaged/Box)

SHIPPING: 3-5 Business days 

SAVEWO 3DMASK ULTRA is an innovative disposable medical respirator. Combining multiple SAVEWO technologies and strict tests, the Ultra series features painless stretchy ear loops and low breathing resistance, making it more comfortable to wear for an extended period.

FEATURES: 

Patented 3D Design - Our patented 3D design fits better to your nose bridge and your face shape in order to prevent air leakage and also fogging for glasses wearers. The series has passed multiple tests of international standards to ensure the filter is working efficiently even in high-risk areas.

- Innovative TYPECOOL+ filtration technology with ultra-high breathability and effective for 24 hours & the filtration maintained 99.9% after soaking in distilled water for 24 hours

Droplet & splash resistance - Combining the all-new UltraSpunBond super water-repellent fabric and the UltraSeal welding technology, 3DMASK Ultra is defined by a firm three-dimensional structure with higher durability, good splash protection and water-resistant ability. Ultra is capable of resisting droplet and splash at a pressure of 160mmHg.

Skin-friendly - Smooth and hydrophilic ESPP inner layer that keeps the mask fresh, preventing it from dehydration while being able to get rid of excess moisture.

Specification and Certifications

• Bacterial Filtration Efficiency BFE≥99.9%
• Particle Filtration Efficiency PFE≥99.9%
• Viral Filtration Efficiency VFE≥99.9%
• Innovative  filtration technology with ultra-high breathability and effective for 24 hours
• Ultra-low breathing resistance <2.4mmH₂O
• Fluid Resistance: Resists Synthetic Blood @ 160mmHg of pressure
• Smooth and hydrophilic ESPP inner layer, skin friendly material
• Conforms with EN149:2001 + A1:2009 FFP2 (EU) respirator standards
• Conforms with KMOEL-2017-64 KF94 (Korea) respirator standards
• Passed NIOSH 42 CFR 84 N95 (US) filtration and breathing resistance test
• Conforms with ASTM F2100-19 Level 3 (US) standards
• Conforms with EN14683:2019 Type IIR (EU) standards
• Passed ISO10993-5 MEM Elution Test and ISO10993-10 Skin Irritation and Sensitization Test, Biocompatibility of medical devices
• Passed the Microbial Cleanliness (Bioburden) Test
• Not containing 212 SVHC high concern materials
• Not containing fluorescein, latex-free and antiallergic
• ISO9001:2015 Quality Management System
• ISO13485:2016 Medical Devices Quality Management System
• ISO14001:2015 Environmental Management System
• ISO14644-1:2015 Class 7 Cleanroom
• CE Marking Certification (EU)
• Regulated by FDA (US), Registration Number: 3017178899
• Regulated by MFDS (KFDA) (Korea), Registration Number: 202107925
• Designed and Made in Hong Kong
• Individual packing