NPPTL Respirator Assessments to Support the COVID-19 Response
Updated October 29, 2020
Assessment of Filtration Efficiency and Manikin Fit for Decontaminated International Respirators 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. At the request of applicants, NPPTL has been assessing the filter efficiency performance of these products for new (not decontaminated) products. Our data shows that the majority of products being submitted for evaluation, are not on the FDA EUAs.
NPPTL is now opening assessments to international respirator products that have undergone a decontamination process. Note: Only unworn respirators which have not been exposed to pathogenic microorganisms can be submitted for assessment. The requestor will put the unworn respirators through a decontamination process and then submit them to NPPTL for filtration and manikin fit assessment.
All submissions must include the respirator manufacturer, the model number/name, the performance standard (See Table 1 below), and the description of the decontamination method that was used. Any submission missing this information will not be assessed. The requestor must also provide information for 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.
CDC published guidance Strategies for Optimizing the Supply of N95 Respirators which was updated on June 28, 2020. This guidance provides Crisis Capacity 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 (Table 1). Respirators conforming to the performance standards listed in Table 1 may be submitted to this test program.
Table 1: Classifications for non-NIOSH approved respirators that may be submitted for testing1
|Country of Certification||Performance Standard||Acceptable Product Classification|
|People’s Republic of China||GB 2626-2006
|Mexico||NOM-116-2009||N95, R95, P95
N99, R99, P99
N100, R100, P100
This assessment of decontaminated international respirators 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.
1 Products conforming to these standards are listed in the CDC Strategies for Optimizing the Supply of N95 Respirators: Crisis/Alternate Strategies (accessed 9/24/2020).
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.
While the above-listed product classifications have similar performance requirements to NIOSH-approved devices, NIOSH 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. Additionally, NIOSH does not endorse, validate, or recommend any decontamination method to be used for any disposable filtering facepiece respirator.
This assessment was developed to evaluate the filter efficiency and manikin fit 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 and manikin fit will be assessed; inhalation and exhalation resistance and human subject 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.