NPPTL Respirator Assessments to Support the COVID-19 Response
Updated October 29, 2020
International Respirator Assessment Request
At the onset of the COVID-19 pandemic, international respirator products, mostly from China, were being imported into the United States. The FDA Emergency Use Authorizationsexternal 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 the majority of products being 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. Any submission missing this information will not be assessed. Requestor must also provide information where the product was purchased/obtained.
Exceptions will be considered for requests made for 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. International Respirator Assessment Requests originating from any of these email domains will NOT be considered.
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 other countries listed in the guidance and their associated product classifications are shown below.
The International Respirator Assessment is a point-of-use assessment and is not to be used by manufacturers, distributers, suppliers, or importers attempting to sell products in the United States. To protect American workplaces, requests from federal and state agencies, employers, and healthcare systems will be accepted. NPPTL initiated these assessments to provide users and purchasers of respirators brought into the US to quantify the product’s filtration efficiency in advance of or before purchases are made from distributors.
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 Emergency Use Authorizations 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
|FFP2, FFP3||Europe||EN 149-2001|
|Korea 1st class||Korea||KMOEL-2017-64|
|N95, P95, R95
N99, P99, R99
N100, P100, R100
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.
This assessment was developed as an assessment of the filter efficiency for those respirator’s represented as certified by a foreign certification authority, other than NIOSH, to support the availability of respiratory protection to US healthcare workers due to the respirator shortage associated with COVID-19. Only particulate filter efficiency will be assessed as inhalation and exhalation resistance and fit testing are not a part of this assessment.
If assessment of multiple models of respirators is being requested, this form should be completed for each model.