Proudly Made in the USA
Proudly Made in the USA
Every MASC product is backed by rigorous testing and world-class certifications, ensuring the highest standards of safety and quality in respiratory protection.
Our commitment to quality is demonstrated through the certifications and regulatory approvals our products and facility have earned. Each certification represents rigorous testing, ongoing compliance, and a dedication to protecting the people who use our products.
The National Institute for Occupational Safety and Health (NIOSH) is the federal agency responsible for approving respiratory protective devices in the United States. NIOSH approval means that our N95 respirator has been tested and certified to filter at least 95% of airborne particles 0.3 microns or larger in size.
The NIOSH approval process involves rigorous laboratory testing of filtration efficiency, breathing resistance, and quality of construction. Products must meet strict performance criteria under standardized conditions before receiving approval. NIOSH also conducts periodic audits and re-testing to ensure ongoing compliance.
The FDA 510(k) premarket notification is a regulatory pathway that demonstrates a medical device is substantially equivalent to a legally marketed predicate device. Our Blue 3-Layer Tie-On Surgical Mask has received 510(k) clearance (K211984), confirming it meets the safety and effectiveness standards required for a Class II medical device.
This clearance means our surgical mask has been reviewed by the U.S. Food and Drug Administration and found to be safe and effective for its intended use in medical settings, including surgical procedures, examinations, and other healthcare environments where fluid resistance and bacterial filtration are critical.
ASTM F2100-19 is the standard specification for performance of materials used in medical face masks. Level 3 is the highest performance category, indicating superior protection against fluids, bacteria, and particulates. Our surgical masks and procedure masks meet this demanding standard.
ISO 13485 is the internationally recognized standard for quality management systems specific to the medical device industry. This certification demonstrates that Mid-America Safety Corp has established and maintains a comprehensive quality management system that consistently meets customer and regulatory requirements for medical devices.
Our ISO 13485 certification is maintained through regular third-party audits, ensuring our quality management system continues to meet the highest international standards for medical device manufacturing.
Title 42, Part 84 of the U.S. Code of Federal Regulations (42 CFR 84) establishes the testing, approval, and quality assurance requirements for respiratory protective devices sold in the United States. This regulation is administered by NIOSH and sets the standards that all approved respirators must meet.
Our N95 particulate respirator (TC-84A-9515) is manufactured in full compliance with 42 CFR Part 84. We maintain detailed quality assurance documentation, conduct all required testing, and cooperate fully with NIOSH site audits. Our in-house testing laboratory allows us to verify compliance on every production batch before products leave our facility.
