Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency (Revised)
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This guidance is being issued by the FDA to address the Coronavirus Disease 2019 (COVID-19) public health emergency. This guidance is being implemented without prior public comment because the Food and Drug Administration (FDA or the Agency) has determined that prior public participation for this guidance is not feasible or appropriate (see section 701(h)(1)(C) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and 21 CFR 10.115(g)(2)). This guidance document is being implemented immediately, but it remains subject to comment in accordance with the Agency’s good guidance practices.
FluShields would like to focus our customers' attention to the fact that we are selling "Face Masks, Face Shields, and N95 Respirators Not Intended for a Medical Purpose" which is stated in section 5.in the above mentioned FDA announcement.
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Good news: You can actually protect yourself from viruses by wearing an FFP3 or N95 respiratory mask: Get your N95 respirator masks for the whole family today.
Please note that we can only pass on general information and cannot guarantee for consequences of your decision making or behavior. Use good common sense and ask your health care provider or physician for advice.
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