Because official testing is still in progress, we are submitting this to be included by the NIH 3D Print Exchange for "Community Use". Therefore, please read and understand our current stance about this as of 4/12/20 at the time this is written and until further notice:

"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."

Youtube video at: https://www.youtube.com/watch?v=xVYypLYEo_0

*99.9% claim is based on previous claim - TESTING IN PROGRESS TO CONFIRM PARTICLE FILTRATION AT THE 0.3 MICRON LEVEL. - will update with results when finalized. Use at your own risk. Educational purposes only: Files are here: thingiverse.com/thing:4262131 This tutorial shows how to make a high filtration mask from blue surgical tray material called Halyard H600, though doing so is not endorsed by the company or guaranteed. This is an adaptation of a mask sewn from this material detailed by Dr. Bruce D Spiess. It has been claimed that both 1 and 2 layers filter over 99% of small particles, implying it is better than n95, but this testing to confirm is underway. Above all else, the most important aspect is a good seal, which this mask strives to create. See Dr. Spiess' sewing tutorial: https://ufhealth.org/news/2020/uf-hea... To apply to 3D printing instead of sewing, we call this the "CEG Extreme". What we did at the Musculoskeletal Institute at UConn was to adapt a face frame to allow 1 or 2 layers of this material to be pressed to your face. You can use elastics or IV/phlebotomy tourniquets cut into 1/3's. Pre-tie the knots and slide into three slots. Tie addition knots to increase tension as needed. The final knot locks in like floss between teeth and avoids the need to pull over the head. Print with 100% infill. Files are open source and you may use it non-commercially to make these masks, per your hospital policy, given the CDC's relaxed guidelines for homemade masks. If you experiment with using this in addition to surgical masks or in other masks or applications, please share what works best for you. We are all in this together trying to find the most safe and creative ways to make it though this pandemic. DO NOT USE in place of approved masks if they are still available and use at your own risk. Christopher Wiles, DO - Anesthesiology Augustus D. Mazzocca, M.S., MD - Orthopedic Surgery & Bioskills Elifho Obopilwe - UConn Musculoskeletal Institute Thank You: Bruce Spiess, MD FAHA - UF Department Anesthesiolgy Michael Baldwin, MD, UConn Radiology Jason Hancock, PhD, UConn Physics Cindy Polinsky, Executive Director UCHC-AAUP Joseph Luciani, Director, Proof of Concept Center, UConn UConn, Hartford Hospital & St. Francis Medicine Residents Orthopedic Surgery Fellows Sean London, MD, Emergency Medicine Ideas and input from many others 2RobotGuy for frame inspiration Disclaimer: These designs represent my own ideas, not an institution's. The efficacy of this mask exoskeleton is not guaranteed. This is a concept for emergency use only and as a last resort. It does not replace approved masks. Use as you see fit, with no guarantees. Files are open source, creative commons non-commercial, share-alike license. To see my other video about a 3D printed respirator that is attempting to reach n95, click here: https://youtu.be/ySOCNycv-aA

To be recommended "For Clinical Use" this will have to pass:

1) fluid resistance testing - samples sent to lab to assess ASTM 1862 standard, meaning it stops blood/fluids, which it is expected to pass but PENDING

2)  Flamability per 16 CFR 1610

3) Air exchange testing - can user breath adequately during 2 minutes CPR while wear mask - yes

4) Bacterial Filtration Efficiency ASTM 2101 - per manufacturer this is verified

5) Sub-micron particulate filtration ASTM F2299 - PENDING confirmation by UConn/Yale, prelim data shows yes, superior to n95 at this.