SafeSource Direct Receives FDA Approval on Masks
May 26, 2022
SafeSource Direct has reached the latest milestone on its journey to becoming America’s leading Personal Protective Equipment (PPE) manufacturer. The Broussard based company is excited to announce that it has received 510(k) approval from the Food and Drug Administration for its surgical and procedure masks.
What is 510(k) approval?
A 510(k) approval is one of the most stringent approvals processes the FDA preforms. This premarket submission verifies that the medical device is safe and effective to be used in a healthcare setting. This process is fundamental to selling any medical device or equipment to any organization providing patient care.
What does this mean for SafeSource Direct and the healthcare industry?
This premarket approval from the FDA was the last step in enabling SafeSource Direct to sell masks to healthcare workers. And with both masks qualifying as approved for Level 1 and Level 3, the PPE manufacturer can begin fulfilling shipments for hospitals, and other healthcare facilities. Customers that have been waiting for approval can now begin placing much anticipated orders. This allows SafeSource Direct to take its biggest step yet in proving that it will be a supply chain resiliency solution for PPE to the healthcare industry.
In addition to receiving this important approval from the FDA, these masks have been certified as compliant with the International Trade Administration’s Berry Amendment, which verifies that all components are domestically manufactured.