438 S. Emerson Ave
Greenwood, IN 46143 USA
MedFab3D is dedicated to supporting our medical community in the greater Indianapolis area during this crisis. MedFab3D is donating face masks to the health care community to support their efforts. MedFab3D face masks come in 4 sizes and need to be fit adjusted for each person. This takes about 20 minutes to complete. MedFab3D will take care of all of the parts and maintenance for the face masks for the duration of the COVID-19 pandemic.
The face masks are 3D printed using our custom orthopedic printers and are made of the same material as water bottles. The masks are durable, stain resistant, and can be cleaned and reused with new filters (provided).
MedFab3D has sourced materials to build approximately 100 masks for health care personnel in the local area and we will extend that number based on demand.
The MedFab3D face masks have been engineered for performance but have not gone through formal NIOSH testing and certification and MedFab3D cannot make any claims about the efficacy of the face mask.The face mask design has been submitted to the NIH / FDA for clinical consideration. The face mask design and production samples have also been submitted to the local Covid-19 Task Force centered at the Roudebush VA Medical Center for evaluation. The face mask comes in Small, Medium, Large and XL sizes. Complete documentation for how to use the mask, care and cleaning can be found in the link below along with complete project documentation. We are also providing a link to the NIH site for our submission.
We are also working with a group out of Stanford University to digitally scan a face using the face unlock - scanner feature of the iPhone 10 and 11 to automatically adjust the shape of the mask to the user. We are working on a modified design that will be adjustable with this technique. If you prefer to wait on a custom size we can scan your facial features and manufacture a custom mask.
The FDA mandates that the following information must be provided with the MedFab3D face mask.
The FDA states that these masks have to be labeled with the following information:
1) This mask may only be used when no FDA approved Personal Protective Equipment (PPE) is unavailable.
2) This mask should not be used in a surgical setting where significant exposure to a liquid, bodily fluid or other hazardous fluids may be expected.
3) The MedFab3D face mask has not been evaluated for antimicrobial or antiviral protection and no claims are made with regard to the effectiveness of the face mask for these properties.
4) This mask has not been evaluated for flammability hazard and no claims are made with regard to the flammability of the mask.
5) The mask is made of FDA approved PETG filament (food contact) and utilizes polyester elastic for a head strap. On an emergency basis the mask may utilize a rubber tape that may contain latex if the mask cannot be fitted to the user.
6) The MedFab3D face mask is labeled a Face Mask and no claims are made to the effectiveness of the mask. The Face Mask should only be used when no other approved Personal Protective Equipment - face masks are available.
Digital Facial Scan Utilizing and IPhone 10XR.
MedFab3D is a startup medical technology company that specializes in digital fabrication (3D Printing) and design technologies. We design and manufacture casts, braces, splints and prosthetic components that are customized to patient needs and manufactured on demand using 3D printing technologies. Our delivery system takes a clinical approach to this method by including the medical providers in our process to provide the inputs that are required to customize products for their patients.