NIOSH, a part of the U.S. Centers for Disease Control and Prevention, in the U.S. Department of Health and Human Services issues recommendations for respirator use. The approval holders worldwide, manufacture NIOSH approved Respirators for use in the United States and internationally.


Respirators are approved in accordance to NIOSH Federal respiratory Regulations 42 CFR part 84.


NIOSH approval is your ticket to the US Market. Maven Profcon Services LLP provide all testing and certification needs from start to finish. We can guide you through every step of NIOSH certification process.


Contact: +91 7490017774 


Our Services

NIOSH Certification

CE under MDD 93/42/EC for Face Mask & Surgical Gowns

CE under PPE 2016/425 for Coverall, N95, Surgical Gowns, Face Shield & Goggles

US FDA (510K) for N95 Mask, Face Mask, Surgical Gown & other COVID 19 devices

US FDA (510K) for IVD devices

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We are Team MAVEN, the Medical device Regulatory experts and the brilliance behind MAVEN PROFCON SERVICES LLP.

We work closely with our clients to ensure all communications and regulatory requirements are transparent and clearly addressed in a timely manner and that exceptional services are delivered with an innovative approach.

Our highly performant team members possess vast expertise in regulatory consulting, medical device engineering, quality assurance, digital and business intelligence, and many with medical device industrial experience in technical fields.