Are Class 1 medical devices that may be used for healthcare purposes but should not be used in surgical or high-risk situations, or in high-risk situations with contact with liquids or infectious materials.
These are Class 1 medical devices and are not subject to FDA 501(k) reporting requirements. These products are made by FDA-registered manufacturers
Disposable hygiene masks
3-layer non-woven fabric with fine filtration and optimal breathability
Comfortable to wear for long periods of time while maximizing protection