Due to Covid-19, my company (in USA) is considering starting manufacturing face masks. I have been searching and have not been able to find answers to the following questions. Any guidance would be welcome.
I understand surgical masks are considered class II by FDA. We currently are FDA registered and have cut and sew capabilities for class I orthopedic devices and do not want to move to class II.
1. Are non-surgical masks considered medical devices?
2. If so, are they class I?
3. If class I, are there any clean room requirements?
4. If not a medical device, are there any other requirements that anyone is aware of? I can only think of any claims that we could not make.
5. If we were to act as a contract manufacturer for the class II surgical mask, would they need to be made in a cleanroom?
I understand surgical masks are considered class II by FDA. We currently are FDA registered and have cut and sew capabilities for class I orthopedic devices and do not want to move to class II.
1. Are non-surgical masks considered medical devices?
2. If so, are they class I?
3. If class I, are there any clean room requirements?
4. If not a medical device, are there any other requirements that anyone is aware of? I can only think of any claims that we could not make.
5. If we were to act as a contract manufacturer for the class II surgical mask, would they need to be made in a cleanroom?
