Harmony Earloop Face Masks meet ASTM F2100-19 as a Level 3 Barrier. This level 3 mask is considered a surgical mask and is manufactured in an FDA Approved Facility. All Masks should fit snugly over your nose and mouth without any gaps and shouldn’t inhibit your ability to breathe comfortably in any way.. Manufactured in FDA Approved Facility Face Masks offer barrier protection and a comfortable fit Blue side faces out 3-ply, 3-fold, fluid resistant Latex free and fiberglass free Disposable, for single use only Metal nose piece conforms to face for a comfortable fit Soft, comfortable elastic ear loops