NPPTL Respirator Assessments to Support the COVID-19 Response
Updated March 30, 2021
International Respirator Assessment Request
IMPORTANT UPDATE:
At the onset of the COVID-19 pandemic, international respirator products, mostly from China, were imported into the United States. The FDA Emergency Use Authorizations (EUAs)external icon provide guidance on the use of these products. NPPTL created the International Respirator Assessment Request to assess the filter efficiency performance of these products. Our data shows that most products submitted for evaluation, are not on the FDA EUAs.
All submissions must include the respirator manufacturer, the model number/name, and verification of the standard that was used. NPPTL will not assess any submission missing this information. Requestors must also indicate where they purchased or obtained the product.
NPPTL will consider exceptions for requests made by federal and state government agencies.
Due to heightened concerns over counterfeiting, NPPTL will require review and validation of emails lacking recognizable company or organizational domains. Examples include emails with domains such as @gmail.com, @yahoo.com, @aol.com, @hotnet.net, @vip.126.com, or @qq.com. NPPTL will NOT consider International Respirator Assessment Requests originating from any of these email domains.
On February 29, 2020, CDC published guidance Strategies for Optimizing the Supply of N95 Respirators. This guidance provides Crisis Alternate Strategies that includes the option: “Use of respirators approved under standards used in other countries that are similar to NIOSH-approved N95 respirators.” The table below shows the other countries listed in the guidance and their associated product classifications.
The International Respirator Assessment is a point-of-use assessment. Manufacturers, distributers, suppliers, or importers cannot use the assessments to sell products in the United States. To protect American workplaces, NPPTL will accept requests from federal and state agencies, employers, and healthcare systems. NPPTL initiated these assessments to provide users and purchasers with results about the product’s filtration efficiency. Purchasers can use this information before making a purchase.
NPPTL has recently received new information from stakeholders across the United States regarding products from China claiming to meet GB2626 and EN149. Assessment results confirm that some of these products have poor filter efficiency and are of poor quality. NPPTL is working closely with the FDA to align EUAs to communicate the point of use testing results.
| Product Classifications | Jurisdiction | Performance Standard |
|---|---|---|
| P2, P3 | Australia/New Zealand | AS/NZS 1716:2012 |
| PFF2, PFF3 | Brazil | ABNT/NBR 13698:2011 |
| KN95, KP95, KN100, KP100 | China | GB2626-2006 GB2626-2019 GB19083-2010 |
| FFP2, FFP3 | Europe | EN 149-2001 |
| DS/DL2, DS/DL3 | Japan | JMHLW-2000 |
| Korea 1st class | Korea | KMOEL-2017-64 |
| N95, P95, R95 N99, P99, R99 N100, P100, R100 |
Mexico | NOM-116-2009 |
While the above-listed product classifications have similar performance requirements to NIOSH Approved devices, CDC does not have knowledge about sustained manufacturer quality system and product quality control for these products. NIOSH also does not have knowledge about the product’s handling and exposures after leaving its manufacturer’s control.
This assessment is not a part of the NIOSH respirator approval process and will in no way lead to or preclude NIOSH approval through the official approval process.
NIOSH developed this assessment to assess the filter efficiency for those respirators represented as certified by a foreign certification authority, other than NIOSH. This effort supports the availability of respiratory protection to U.S. healthcare workers due to the respirator shortage associated with COVID-19. NIOSH will only assess particulate filter efficiency. Inhalation and exhalation resistance and fit testing are not a part of this assessment.
To submit an assessment of multiple models of respirators, requestors should complete this form for each model.
NPPTL requires requestors to send 10 samples for the International Respirator Assessment. The assessment is destructive and the samples cannot be reused. Please see the International Respirator Assessment Planpdf icon for additional information.
This request form is only for respirators that NPPTL has not assessed. Please check the International Respirator Assessment Results to see if we have already assessed the product you have.
* See examples in the CDC Strategies for Optimizing the Supply of N95 Respirators: Crisis/Alternate Strategies