***See the Documentation tab for detailed information including the Instructions for Use, Manufacturing Instructions, Bill of Materials, and Test Report***

The SLUHN FI 3d Mask is designed to be a suitable replacement for a respirator (N95) face mask due to the N95 filter selected. 

This device is intended to be used only for the duration of the public health emergency related to COVID-19 declared by the Department of Health and Human Services (HHS), including any renewals made by the HHS Secretary in accordance with section 319(a)(2) of the Public Health Service Act (PHS Act) (42 U.S.C. 247d(a)(2)).

The decision to implement this device should be made with careful consideration and under the consultation of the corresponding institution’s occupational health and infection control departments. This mask was created as an emergency action to provide our hospital with Personal Protective Equipment (PPE).

Mask has 6 main components:

• Mask body
• Grill cover
• Silicone Gasket
• Filter
• Elastic Strap
• Goggle Clip

Notables of Mask:

1. 3D Printed Mask Body: comes in four sizes, medium, medium deep, large, and large deep – to ensure unobstructed view and optimum breathing space
2. 3D Printed Grill Cover: 3 slots on each side for user to adjust elastic for best fit and seal
3. Filter: FDA cleared KN95 face mask to use as filter material
4. 3D Printed Goggle Clasp: provides user ability to adjust elastic strap for best comfort

Filament: TPC at 45D Shore Hardness is the suggested material

We thank those who have contributed to this project for their dedication and support:

• Megan Augustine (St. Luke’s University Health Network)
• Jennifer Lucas (St. Luke’s University Health Network)
• Michelle Rieder (St. Luke’s University Health Network)
• Dexter Valley (St. Luke’s University Health Network)
• Hunter Davis (St. Luke’s University Health Network)
• JR Kushnir (St. Luke’s University Health Network)
• Michael Gorski (Filament Innovations)
• Ryan Brown (Filament Innovations)