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.
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.
- 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