Dear author,

Thank you for submitting your design to the NIH 3D Print Exchange.

You are receiving this message because your submission uses terminology that may not reflect the device function. Any term used in the title, description, or documentation must conform to the guidelines outlined by the FDA. There is no record of your device meeting the specific standards required to be labelled as a "Surgical mask alternative" or "spash and liquid protection". Any instance of the term "Surgical mask alternative" will be replaced with “community use face mask" and any language regarding "spash and liquid protection" will be omitted so that there is no miscommunication with users of the NIH 3D print exchange about the efficacy of PPE on the site. Please let us know if you would prefer not to accept the changes, and we will instead place your design back into prototype status. Please let us know if the changes in terminology are not acceptable within 3 business days (1/15/21).

Thank you.

This device is a general purpose face mask intended for use in the community and is not suitable for use by a healthcare professional or in a healthcare facility or environment, as described in FDA Guidance Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency, Section V B. This device has not been tested to assess the out-gassing limits of the material or their corresponding health effects.

The name of the design has been changed to adhere to FDA guidelines on labeling. Product cannot be labeled "surgical" unless it meets specifics standards laid out in the FDA guidelines.