What standards apply to the COVEX Face Shield with respirator?

Face shields intended for a medical purpose are regulated by FDA under 21 CFR 878.4040 – Surgical apparel. These devices are classified as class I (general controls) and are exempt from the premarket notification requirements in 21 CFR Part 807 (“510(k) clearance”).

There is currently no universal standard for face/eye protection from biological hazards.1 Nevertheless, OSHA’s applicable standard (1910:1030 subpart (d)(3)(i)) states as follows: “Masks in combination with eye protection devices, such as goggles or glasses with solid side shields, or chin-length face shields, shall be worn whenever splashes, spray, spatter, or droplets of blood or other potentially infectious materials may be generated and eye, nose, or mouth contamination can be reasonably anticipated.”2

The FDA has issued guidelines applicable during the current emergency: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enforcement-policy-face-masks-and-respirators-during-coronavirus-disease-covid-19-public-health?utm_campaign=2020-04-02%20COVID-19%20Face%20Mask%20Webinar&utm_medium=email&utm_source=Eloqua

ASI believes that the portion of the device referred to as the “respirator” complies with the following CDC/NIOSH definition of the term: “A respirator is a personal protective device that is worn on the face or head and covers at least the nose and mouth.”

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