Do You Want Your N95 Respirator in the U.S.?
An N95 mask is a disposable respirator that is NIOSH(National Institute for Occupational Safety and Health) approved. This type of respirator is designed to filter non-oil-based particles and is 95 percent efficient at filtering these particles out. It’s a tight-fitting respirator, also referred to as a filtering face piece.
N- Not Resistant to Oil
Filters at least 95% of airborne particles.
NIOSH is part of the U.S. Centers for Disease Control and Prevention,in the U.S. Department of Health and Human Services. NIOSH issues recommendations for respirator use. Respirator approvals are in accordance to the NIOSH Federal Respiratory Regulations 42 CFR Part 84.
LOOKING FOR NIOSH CERTIFICATE?
WE OFFER INSIGHTS TO THE N95 MANUFCTURERS
We are here to tailor your needs
- Guidance in deciding the type of application
- Assist in Technical Documentation
- Testing as per NIOSH standards
- Filing the SAF
- Submission of application to NIOSH
- Support during on-site audit
- Who can apply for NIOSH approval?
A company or other organization that designs, manufactures, assembles, or controls the assembly of a respirator may apply to NIOSH to become an approval holder.
- In which language all the documents and application should be submitted?
All the documents and application must be submitted in English. Any files created in a language other than English will be returned unprocessed.
- What test are to be performed?
Test for filter efficiency and breathing resistance are performed.
- Will NIOSH test my respirator?
Yes, the manufacturer will have to send hardware samples as per NIOSH requirement.
- How many samples are required for testing?
26 samples of each type of respirator will be tested.
- Is site audit mandatory?
- Do I need to submit QA manual?
Yes, the quality manual is to be submitted along with the initial Application itself. The Quality Manual must cater to the needs described by NIOSH.
- Can I get my respirator approved if my company is not based in the US?
- Approximate time for NIOSH approval?
It can take up to 6 months to get final approval from NIOSH.
- What is a surgical respirator?
A surgical N95 respirator is a NIOSH certified N95 respirator which is simultaneously approved under FDA- 510(K) as a Class II medical device.
This respirator can then be sold under medical claims, for use in clinical set-ups. We, at Maven Profcon Services can guide the manufacturer for the FDA listing and 510(K) approval.