Minimalist yet Extraordinary
SAVEWO ClassicMask is the only Made-in-Hong-Kong surgical mask that has cleared the US FDA 510(k) Class II Medical Device regulations with ASTM Level 3 certification. Available in three classic and minimalist tones—white, grey, and black—its simple, unadorned colors and design perfectly satisfy the desire for a return to simplicity. However, when it comes to exceptional performance and quality, we never compromise.
Featuring a V-shape contour design, it is both aesthetically pleasing and snug. Produced with custom-made materials and comfortable, soft ear loops, it offers a pain-free wearing experience. Enhanced by TYPECOOL+ filtration technology, it effectively maintains ultimate filtration efficiency and ultra-high breathability for over 24 hours.
Utilizing a specially formulated ESPP skin-friendly smooth inner layer, it is completely lint-free to protect your skin. It complies with both the US ASTM Level 3 and the EU EN14683:2019 Type IIR surgical mask standards.
SAVEWO ClassicMask FDA 510(k) Cleared ASTM Level 3 Surgical Mask (30 pcs/box, individually wrapped)
Colors:
- White - Versatile
- Grey - Sophisticated
- Black - Stylish
3-Folded Flat Mask
Ultra-fast fit｜High Breathability｜High filtration
Unfolded: 125 x 85 mm / Target: Suitable for Age 2-6 Kids
Unfolded: 145 x 85 mm / Target: Suitable for Age 7-13 Kids
Unfolded: 160 x 95 mm / Target: Suitable for 90% of adults, ideal for ladies
Unfolded: 175 x 95 mm / Target: Suitable for 90% of adults, ideal for gentlemen
Product Specifications:
- Cleared under US FDA 510(k) Class II Medical Device Regulations
- Bacterial Filtration Efficiency (BFE) ≥ 99.9%
- Particle Filtration Efficiency (PFE) ≥ 99.9%
- Viral Filtration Efficiency (VFE) ≥ 99.9%
- Innovative TypeCool+ filtration technology provides ultimate filtration and extreme breathability. It sustains filtration efficiency durably for over 24 hours.
- Ultra-low breathing resistance: < 3.4 mmH₂O
- Fluid splash resistance up to 160 mmHg
- Specially formulated water-resistant ESPP smooth skin-friendly inner layer that protects the skin and is completely lint-free.
- Complies with US ASTM F2100-19 Level 3 surgical mask standard.
- Complies with EU EN14683:2019 Type IIR surgical mask standard.
- Passed ISO10993-5 cytotoxicity and ISO10993-10 skin irritation and sensitization biocompatibility tests for medical materials.
- Passed Microbial Cleanliness (Bioburden) Test.
- Utilizes the safest masterbatch dyeing method.
- Free of 235 Substances of Very High Concern (SVHC).
- No Azo Dye in textile.
- Fluorescent-free, latex-free, and hypoallergenic.
- Manufactured in an ISO14644-1 Class 7 cleanroom certified facility.
- ISO13485:2016 Medical Devices Quality Management System certified.
- Registered with the US FDA (Food and Drug Administration), Owner/Operator Number: 3017178899.
- Designed in Hong Kong, Made in Hong Kong, individually wrapped.
