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Our product is manufactured in compliance with the FDA Emergency Use Authorization (“EUA”) for Surgical Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency (Revised August 5, 2020). We currently have 2 surgical mask products that have been submitted for Level 1 and Level 3 approvals per ASTM testing protocols by the FDA under the most recent EUA. All of our products currently use materials which meet the testing requirements for use of our masks in medical procedural settings where exposure to liquid or bodily fluids may be expected. Upon approval, our company and surgical masks will be listed on the FDA website which will verify our status by Level.
Level 3 Surgical Masks
• Partical Filtration Efficiency (PFE): > 98%
• Bacterial Filtration Efficiency (BFE): > 98%
• Fluid Resistance Testing at 160mm Hg1: Passed
• Delta P Differential Pressure: < 5.0 mm
• Flammability: Class 1
• Click here for full test results
Level 1 Surgical Masks
• Particle Filtration Efficiency (PFE): > 95%
• Bacterial Filtration Efficiency (BFE): > 98%
• Fluid Resistance Testing at 160mm Hg1: Passed
• Delta P Differential Pressure: < 4.0 mm
• Flammability: Class 1
LEVEL 1 & 3 Tested
Our medical procedural grade surgical masks have been tested to the highest standards per ASTM. All of our masks including our base disposable models are tested to a minimum of ASTM level 1 standards, while our Level 3 Masks are tested to the highest ASTM standards. All of the masks we produce meet the medical procedural use requirements.
FDA Registration #: 3017153452
Made in USA and regulated by the FDA is about ensuring an uninterrupted supply of reliable quality masks for our medical facilities, staff and essential workers around the country. Our masks are manufactured using ASTM tested materials that provide the most protection for its user.
Our Goal: 100% US Sourced Materials
Nearly 90% of domestic mask supplies and materials were sourced from overseas early in the pandemic. We are on the verge of having 100% of our mask materials sourced from US manufacturers, thus ensuring a secure supply chain.
State of the Art Equipment
Our state-of-the-art ultrasonic welding technology provides a consistent, reliable product, assuring customers that consistent high-quality standards are met. Our integrated artificial intelligence (AI) based technology, with its high efficiency, allows us to produce masks at competitive prices.
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