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The U.S. Food and Drug Administration (FDA) has granted emergency use authorization for the Oxiris filter to treat certain COVID 19 patients for no longer than the duration of the COVID 19 public health emergency, as deemed by the Secretary of the Department of Health and Human Services (HHS). The FDA has not cleared or approved the Oxiris set.

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The requirements for an N95 mask and test procedure that are used prior to certification can be found at 42 CFR Subpart K Non Powered Air Purifying Particulate Respirators , subsecti on §84.170 to §84. 182 Non powered air purifying particulate respirators; description.

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Available in PDF (316KB). The Cosmetics Labeling Guide provides step by step help with cosmetic labeling, with examples and answers to questions manufacturers often ask about labeling requirements