US · 42 CFR Part 84
Respirators: NIOSH approval and configuration
Identify the market and product category first. Each dossier separates legal duties, referenced standards, evidence and the comparison needed for an award.
Product Scope
Respirators represented as NIOSH-approved; occupational selection/use and medical-device claims have additional regimes.
Requirements
Verify the approval number, manufacturer and complete approved configuration against the current Certified Equipment List and approval label. Filters and facepieces cannot be freely combined outside that configuration. A private laboratory filtration report is not NIOSH approval.
Required Evidence
Current approval/listing, approval label, full configuration and applicable performance test records.
Comparison for the Awards
Filtration and breathing resistance claims must use the same approved method and conditioning; a higher nominal class is not a substitute for configuration-specific proof.
Version & Transition
NIOSH list status can change; verify at review and publication. This record does not claim approval for any applicant.
Official Sources
Applicability depends on the product classification, intended use, configuration and actual sales territory. Manufacturing, placing-on-the-market and testing dates, together with transition provisions, are checked as required by each applicable rule. The directory identifies sources; it does not replace assessment of the specific model. Standards are identified by reference, and their authoritative texts remain with the issuing bodies. Official source documents retain their original language.