At SafeSource Direct, we offer a full line of American-made face masks designed for healthcare professionals, institutions, and individuals who demand the highest level of protection and quality. From ASTM Level 1 surgical masks and Level 3 procedure masks to NIOSH-approved N95 respirators and child-sized 3-ply face masks, our products meet or exceed strict U.S. medical standards.

MASKS MADE IN THE USA TO THE HIGHEST STANDARDS

Explore Our Medical Face Mask Options

Masks

N95 Surgical Cup Respirator

Item # SCR3001

Masks

3-Ply Face Mask

Item # FM3001

Masks

Child Masks

Item # CM3001

Masks

3-Ply Procedure Mask (Level 3)

Item # PM3003

Masks

3-Ply Procedure Mask (Level 1)

Item # PM3001

Masks

Surgical Tie Mask (Level 1)

Item # SM3001

Why Choose SafeSource Direct Masks?

  • 100% U.S.-based manufacturing

  • Vertical integration for supply chain resiliency

  • 510(k) FDA cleared masks available

  • ASTM Level 1 & Level 3 options

  • NIOSH-certified N95s

  • Designed for hospitals, clinics, and other bulk buyers

  • Competitive Pricing

 

Made in the USA. Backed by Compliance.

We are a vertically integrated PPE manufacturer, which means we control every step of production—from raw materials to delivery—ensuring consistent quality and secure supply chains. Many of our masks are FDA 510(k) cleared and produced in ISO-certified U.S. facilities. All masks are produced in our Louisiana facilities and meet or exceed the following standards:

 

  • ASTM F2100-21 for fluid resistance, filtration, and breathability
     

  • NIOSH 42 CFR Part 84 for N95 respirators
     

  • FDA 510(k) clearance on eligible products
     

  • ISO 13485 certified manufacturing practices

 

Frequently Asked Questions

What is the difference between Level 1 and Level 3 surgical masks?

Level 1 masks provide low barrier protection for general use. Level 3 masks offer higher fluid resistance and filtration for environments with increased exposure to splashes or aerosols.

Are your masks FDA-approved or NIOSH-certified?

Yes. Our N95 masks are NIOSH-certified, and several of our surgical and procedural masks are FDA 510(k) cleared. Certifications are noted on each product page.

Do you manufacture in the United States?

All our face masks are manufactured in the U.S., helping healthcare providers and institutions avoid overseas supply chain risks.

Can I purchase masks in bulk?

Yes, we support high-volume orders for healthcare systems, government entities, and organizations. Contact our sales team for bulk pricing.