DtM lightweight Remix

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:

Benjamin Jones

Tue, 2020-04-07 09:44

Vertical Tabs

General Information

Model ID

3DPX-013616

Category

Labware & Devices

Device Use

Safety and Personal Protective Equipment

Keyword(s)

3D Printed Face Shield PPE Personal Protection Equipment Mask Waterjet

A lightweight remix of the DtM shield optimized for 3d printing (1 hour), waterjet machining (2 min), and CNC router (2min). Laser cut shield.

changed headband attachment to work with phlebotomy tournequit
extended shield to 12.25" wide to provide better side coverage
added 'hooks' to tabs to better retain shield

3D Modeling/CAD Software

Rhino 3D

How to Make

Printer Technology/Material

Other

Printer Make/Model

CNC Router

CNC waterjet

Attribution

Attribution Instructions

University of Cincinnati

Office of Innovation

Documentation

Supplemental Documentation

1819 _Shield_IFU.docx

DtM Face Shield- EUA Letter-20200423.docx

Reviewer Notes

Dear Author,

Please update the following details regarding your upload in order for us to move this further in approval queue:

- Not clear how to use phlebotomy tourniquet onto the headband - need further instructions.

- You have a "pad" file listed online - please include instructions on how to use it

- We will need to have an IFU attached to your design.

- 05.05.20

The following refers to:

3dpx-013616

The FDA has authorized production of face shield 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 shield has undergone review in a clinical setting and is recommended when fabricated as instructed.