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Surgical Masks and Respirators: 21 CFR (FDA) Surgical masks sold in the US are regulated under 21 CFR Section 878.4040: Surgical apparel by the FDA. According to the definition provided by the FDA, surgical masks are intended to protect both the wearer and the patient from microorganisms, body fluids, and others.

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Wearing an FFP3 mask, you’ll be protected from inhaling solid particles, non-volatile liquid particles and oil-based mists. FFP3 face masks are the standard that the NHS demands for its staff. The level of protection is greater than that offered by FFP1 or FFP2 masks. N95 masks – US standard. N95 face masks must meet US standards.

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There are several accredited testing companies that provide MDD testing services for face mask products, which include Bureau Veritas, SGS, Intertek, and TUV. Quality Management System (ISO 13485) If your surgical masks are classified as sterile, then the MDD requires that the manufacturer has a quality management system (QMS) in place.

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Face Masks: Not Enough Are Made In America To Deal With - NPR. Mar 5, 2020 A global shortage of face masks is prompting concern for the safety of health care workers. Now the U.S. government is trying to bring back an industry that one of the few manufacturers of respirators and surgical face masks . Nonwovens Testing Consumer Goods and Retail SGS

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Comparison of FFP2, KN95, and N95 and Other Filtering Facepiece Respirator Classes Description Filtering facepiece respirators (FFR), which are sometimes called disposable respirators, are subject to various regulatory standards around the world. These standards specify certain required physical properties and performance characteristics in

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Based on this comparison, it is reasonable to consider KN95(China GB2626-2006), KF94 (Korea KMOEL - 2017-64) as “equivalent” to N95 (United States NIOSH-42CFR84) and FFP2 (Europe EN 149-2001) respirators, for filtering non-oil-based particles such as those resulting from wildfires, PM 2.5 air pollution, volcanic eruptions, or bioaerosols (e.g. viruses).

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