NoteNovolex PPE products are Class I medical devices that have NOT been FDA cleared or approved. They are authorized under Emergency Use Authorizations (April 13, 2020 for face shields and May 22, 2020 for gowns in low or minimal risk situations) for use as PPE by healthcare providers. The PPE products are only authorized for the duration of the emergency declaration or the relevant EUAs. Please see product literature for specific instructions for use and claims.