The Food and Drug Administration (FDA) reissued certain emergency use authorizations (EUAs) for decontamination systems used with compatible N95 respirators.

Under the new restrictions, impacted decontamination systems that could previously be used on an N95 respirator up to 20 times can now be used a maximum of four times.1 As a result, healthcare facilities will need a larger supply of N95 respirators as they continue to fight COVID-19.

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The FDA defines PPE decontamination systems as “devices intended to decontaminate certain medical devices (such as compatible respirators) so that they can be reused by healthcare personnel.”2

According to the FDA, these sudden, drastic changes were made to “protect the public health or safety” following the review of evidence and research that indicated N95 respirator failures from simulated and real-world use.

EUA renewals included Advanced Sterilization Products, Battelle, Sterilucent, Steris, Stryker, and Technical Safety Services.1

The EUAs originated to help alleviate supply shortages of personal protective equipment due to the COVID-19 pandemic.

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Learn more on our COVID-19 resources page.

  1. Lasek, A. (2021, January 26). FDA limits N95 respirator reuse to four times with PPE decontamination systems. Retrieved from https://www.mcknights.com/news/clinical-news/fda-limits-n95-respirator-reuse-to-four-times-with-ppe-decontamination-systems/
  2. U.S. Food and Drug Administration. (2021, January 22). Decontamination systems for personal protective equipment EUAs. Retrieved from https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/decontamination-systems-personal-protective-equipment-euas#:~:text=Decontamination%20Systems%20for%20Personal%20Protective%20Equipment%20EUAs,-Share&text=Decontamination%20systems%20are%20devices%20intended,be%20reused%20by%20healthcare%20personnel