Box of 50 Masks

Box of 50 Masks

Regular price $35.00 Sale price $15.00
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Shipping calculated at checkout.

With comfort in mind, our form-fitting masks are designed with comfortable ear loops and a soft white inner layer. It is also breathable and hypoallergenic.

SURGISYL Masks are registered with the U.S. Food and Drug Administration (FDA) under the operator number 10078028. 

FDA Device Classification Name: FACE MASK FOR GENERAL PUBLIC/HEALTHCARE PERSONNEL PER IIE GUIDANCE. 

HSA License ES0501141
FDA Establishment Owner 10078028
EN 14683:2019 Type IIR
BFE (%) 99 
PFE (%) 99 
ASTM F2100-19 Level Level 3 
Breathability (Delta P) <60Pa/cm2. 
Microbial Cleanliness <30cfu/g. 
Synthetic Blood Penetration Test
16.0 kPa. 
Our mask making machines

A sneak peek into our factory production. All of our face masks are manufactured and packed locally.

OUR COMMITMENT TO QUALITY

BSI Medical Devices Quality Management Certified

The ISO 13485 standard is an effective solution to meet the comprehensive requirements for a QMS. Adopting ISO 13485 provides a practical foundation for manufacturers to address the regulations and responsibilities as well as demonstrating a commitment to the safety and quality of medical devices.

View Certification