Stopgap Surgical Face Mask (SFM) Revision B

Model Description

This model sourced with permission from the NIH 3D Print Exchange*

Model ID
3DPX-014168
Category
Labware & Devices
Device Use
Safety and Personal Protective Equipment
Keyword(s)
PPE, face mask, surgical mask, filter, COVID-19, Corona virus
Stopgap Surgical Face Mask (SFM) Revision B

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

*** See the “How to Make” tab for build files ***

This mask should only be printed with Multi-Jet Fusion (MJF) or Selective Laser Sintering (SLS) technologies using powder-bed nylon, or Stereolithography (SLA) using BioMed Clear. This device has not been tested to assess the out-gassing limits of the material or their corresponding health effects.

*** Updates coming ***
We hope to expand our filter and cleaning options. Please check this site for updates.
******

The Stopgap Face Mask was created as an emergency action in an effort to protect people by providing backup PPE options if the standard PPE has become unavailable. This device has not gone through the same regulatory approval process as standard PPE.

The Stopgap Face Mask consists of two main components (the mask body and the filter cover) and contains features for attaching two elastic straps and receiving a patch of filter material. It is recommended that the rectangular filter patch and elastic straps are disposed of after every use of this device. The remaining parts of the plastic mask can be disinfected using common disinfecting solutions or sterilized and reused.
Revision B of the Stopgap Surgical Face Mask includes the following improvements:
• Improved breathability
o Reduced internal volume to minimize recycled air
o Larger filter area to reduce pressure drop
• Improved fit
o 3 sizes now available (small, medium, large)
o All sizes have changed to improve fit (check to see if the best fit size has changed for you)
o Flange near face reduced to improve mask flexibility
o Mask angles changed to reduce hard edges in contact with face
• Improved cover snap – better retention and easier to remove

For Revision A, see model 3DPX-013429

Many people contributed to this project and we thank them for their dedication and support:
• Patrick Aubin (Veterans Health Administration)
• Sarah Bastawrous (Veterans Health Administration)
• Jared Bliss (Veterans Health Administration)
• Brian Burkhardt (Veterans Health Administration)
• William Chang (Veterans Health Administration)
• Timothy Davis (Veterans Health Administration)
• Kathleen Decina (Veterans Health Administration)
• Darin Desmond (Veterans Health Administration)
• Stuart Fairhurst (Veterans Health Administration)
• Michelle Gibson (Veterans Health Administration)
• Joseph Iaquinto (Veterans Health Administration)
• Eli Kaufman (Veterans Health Administration)
• Matt Kindig (Veterans Health Administration)
• William Ledoux (Veterans Health Administration)
• Joe Li (Veterans Health Administration)
• Steve Morin (Veterans Health Administration)
• Queenie Ngo (Veterans Health Administration)
• William Nylander (Veterans Health Administration)
• Chris Richburg (Veterans Health Administration)
• Beth Ripley (Veterans Health Administration)
• Brian Strzelecki (Veterans Health Administration)
• Roger Tatum (Veterans Health Administration)
• Luis Tulloch-Palomino (Veterans Health Administration)
• Greg Voss (Veterans Health Administration)
• Matthew Di Prima (Food and Drug Administration)
• James Coburn (Food and Drug Administration)
• Anthony Anderson (University of Washington)
• Lynda Brady (University of Washington)
• Colleen Carroll (University of Washington)
• Alex Hotz (University of Washington)
• Mark Ganter (University of Washington)
• Ian Good (University of Washington)
• Liang He (University of Washington)
• Dalton Hildreth (University of Washington)
• Yuri Hudak (University of Washington)
• William Lack (University of Washington)
• Jing-Sheng Li (University of Washington)
• Dmitry Levin (University of Washington)
• Jeffrey Lipton (University of Washington)
• Kelly Mack (University of Washington)
• Jen Mankoff (University of Washington)
• Connor Mulcahy (University of Washington)
• Alshakim Nelson PHD (University of Washington)
• Monica Ortiz (University of Washington)
• Jonathan Posner (University of Washington)
• Annie Ross (University of Washington)
• Anastasia Schaadhardt (University of Washington)
• Adriana Schultz (University of Washington)
• Anne Turner (University of Washington)
• Megan Hofmann (Carnegie Mellon)
• Scott Hudson (Carnegie Mellon)
• Jim McCann(Carnegie Mellon)
• Aidan Fay (Stanford University)
• Elizabeth Foster (3D Systems Healthcare)
• Benjamin Johnson (3D Systems Healthcare)
• Shelby Marks (3D Systems Healthcare)
• Jacob Ames (Hawk Ridge Systems)
• Brandon Boulden (Hawk Ridge Systems)
• Tristan Butler (Hawk Ridge Systems)
• Mark Dolinar (Hawk Ridge Systems)
• Matthew Fisher (Hawk Ridge Systems)
• Josh Hall (Hawk Ridge Systems)
• Devin Johnson (Hawk Ridge Systems)
• Douglas Nicklin (HP)
• Jack Aubin
• Kavi Dey
• Caitilynn Larmore
• Kelly Richburg
• Sherry Sellentin (Pacific Fabrics and Crafts)
• Kathie Varney (Pacific Fabrics and Crafts)
• Karen Grosh (Pacific Fabrics and Crafts)
Segmentation Software
N/A
3D Modeling/CAD Software
Solidworks
Model Origin
Custom illustration/CAD
Printer Technology/Material
Nylon

Vat Photopolymerization
Printer Make/Model
Many
Print Units
mm
Pre- and Postprocessing Instructions
See Documentation tab, manufacturing instructions
Attribution Instructions
Please credit “Stopgap Face Mask (SFM)” for all use and derivative work.
Reviewer Notes
The following refers to 3DPX-014168 Stop Gap Surgical Face Mask:

The FDA has authorized production of protective face masks outside of the normal clearance pathway during the COVID-19 pandemic, based on Part 5, section E 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 surgical face mask has been tested clinically and meets the requirements of relevant FDA Guidance.

*This surgical face mask must be fabricated in a ISO 13485 compliant/ current Good Manufacturing Practices certified facility under an appropriate quality management system*

Files

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TDP Category Type Filename Size
General Instructions application/pdf COVID-19_surgical_mask_checklist.pdf 2.59 MB
General Instructions application/pdf Stopgap Face Mask (SFM) - 3D Systems Manufacturing Guidance - Rev F.PDF 638.69 KB
General Instructions application/pdf Stopgap Face Mask (SFM) - Bill of Materials_Rev B.pdf 219.27 KB
General Instructions application/pdf Stopgap Face Mask (SFM) - EOS Manufacturing Guidance - Rev A_0.pdf 277.38 KB
General Instructions application/pdf Stopgap Face Mask (SFM) - Formlabs Manufacturing Guidance - Rev [1.5].pdf 904.78 KB
General Instructions application/pdf Stopgap Face Mask (SFM) - HP Multi Jet Fusion Manufacturing Guidance - Rev C_0.pdf 270.33 KB
General Instructions application/pdf Stopgap Face Mask (SFM) - Instructions for Use_Rev 6.pdf 1.96 MB
General Instructions application/pdf Stopgap Face Mask (SFM) - Test report Rev B.pdf 108.36 KB
Native CAD SFM RevB Large.SLDPRT 4.98 MB
Native CAD SFM RevB Medium.SLDPRT 4.19 MB
Native CAD SFM RevB Small.SLDPRT 5.32 MB
Native CAD SFM RevG Cover.SLDPRT 488.73 KB
Native CAD HP MJF 500 Series Optimized Build (Rev B Mask & Rev G Cover).3mf 8.62 MB
Native CAD HP MJF 4200 & 5200 Series Optimized Build (Rev B Mask & Rev G Cover).3mf 22.11 MB
STL File SFM RevB Large_0.STL 2.89 MB
Blender-generated-x3d SFM RevB Large_0.STL60c0e587f2f70.x3d 2.04 MB
STL File SFM RevB Medium_0.STL 2.85 MB
STL File SFM RevB Small_0.STL 2.89 MB
STL File SFM RevG Cover_0.STL 301.25 KB

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Part Information

Additional Owner's Names

jknotts

AMCPR Type

designPackage

Model Number

3DPX-014168

Review Process

simple

Public

Yes
2021-06-09T15:59:35

Materials

Polymer

General Build Material

PA

Exact Build Material

Nylon

AM Process

Vat Photopolymerization

Quality Standards

Submission Path

production

Assembly Required

No
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