Micro-Shield has been authorized by FDA under an Emergency Use Authorization (EUA) for use by the general public and health care personnel (HCP) as source control to help prevent the spread of infection or illness during the COVID-19 pandemic.
Scope of Authorization: Micro-Shield is limited to use as source control for members of the general public, including health care personnel (HCP) in healthcare settings, to cover their noses and mouths, in accordance with CDC recommendations, to prevent the spread of the SARS-CoV-2 during the COVID-19 pandemic.
Materials: Polyester and Spandex.
Recommended Use: Micro-Shield is recommended for use by the general public as source control to help reduce person-to-person transmission.
Unauthorized Use: Micro-Shield is not recommended for use in any surgical setting or where significant exposure to liquid, bodily or other hazardous fluids, may be expected; use in a clinical setting where the infection risk level through inhalation exposure is high; and use in the presence of a high intensity heat source or flammable gas.
Cleaning and Care: For recommended cleaning and care instructions, please click here for Micro-Shield and click here for Nano-Shield.
Adverse event reporting: If you experience any adverse events associated with the use of this product, please click here to fill out a complaint form.
This product has not been FDA cleared or approved.
This product is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of medical devices, including alternative products used as medical devices, during the COVID-19 outbreak, under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1) unless the authorization is terminated or revoked sooner.