Medical Mask Testing Requirements Guide: FDA 510(k) Submission
Understanding face mask testing requirements can be especially difficult during a global pandemic. If you are manufacturing medical masks under the FDA's emergency use authorization (EUA) and/or would like assistance with the FDA 510(k) submission requirements, Intertek can help.
Following the ASTM F2100 standard, Intertek developed this guide to help manufacturers understand the various test requirements, and the mask certification process.
Please complete the form to download the guide and receive support.