Mask Fitter by Bellus3D

This design has undergone review in a clinical setting and has been found appropriate when fabricated with the printer type and materials specified.

Submitted by:

Bellus3D

Mon, 2020-04-13 21:52

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General Information

Model ID

3DPX-013836

Category

Labware & Devices

Device Use

General Equipment or Adapter

Keyword(s)

3D Printed Face Mask

Bellus3D's Face Mask Fitter is a plastic frame that helps to improve the seal with surgical masks or similar face masks. It is made using a Bellus3D face scan (created with the Bellus3D FaceApp) and a 3D printer to precisely fit a person's facial geometry.

Attached is one example that fits about 15% of the population. You can download the Bellus3D FaceApp (https://apps.apple.com/us/app/bellus3d-faceapp/id1352268131), scan your face and output a personalized STL to use on your 3D printer. You don't need to create an account or pay to make your own, personalized Mask Fitter.

Mask Fitter is a personalized device intended for use by individuals. More information can be found here: https://bellus3d.com/solutions/facemask.html

Attribution

Attribution Instructions

By Bellus3D, Inc. https://bellus3d.com/solutions/facemask.html

Reviewer Notes

The following refers to: 3dpx-013836

The FDA has authorized production of face mask outside of the normal clearance pathway during the Covid-19 pandemic, based on Part 5, section D of the “Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency Guidance for Industry and Food and Drug Administration Staff.”

This face mask has undergone review in a clinical setting and is recommended when fabricated as instructed.

RESOLVED:

05.02.20 For documentation purposes, we cannot accept links to external websites for printing instructions, instructions for use, etc. Instructions need to be included as a PDF or as text on the NIH 3D Print Exchange website.