The reusable respirator has not been evaluated by the FDA, and Intermountain 3D makes no warranties as to its efficacy in any specific situation. It is being offered as a stopgap to healthcare providers in this time of shortage. However, great care has been taken to insure the safety of users of the mask.
Respirator Components
The reusable respirator is comprised of a 3D printed mask, sealing strip, elastic straps and filter media made from Halyard H600 2-ply spun polypropylene (surgical wrap). Other N95 or equivalent media can also be used.
Respirator Specifications:
- Body of respirator is 3D printed using bio-compatible nylon 12 material which has passed the ISO 10993-5 (Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity) and ISO 10993-10 (Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitization) standards
- Respirator has been tested with an N95 filter using the N95 Respirator Fit Test with Challenging Agent at St Alphonsus Hospital, and passed all tests.
- Respirator has also been tested using filters made of Halyard H600 2-ply spun polypropylene (surgical wrap) and passed all N95 tests
- Respirator currently comes in three sizes, medium, small, and extra small, and healthcare workers should complete a fit test to determine correct size
