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ASTM standards are referenced by the Food and Drug Administration (FDA), as the endorsed standard in the United States. The current standard ASTM F2100-11 (2011) specifies the performance requirements for Medical Face Masks with five basic criteria: 1.

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Medical surgical mask quality standards. Medical surgical masks in the United States need to be approved by the FDA. They require certain particle filtration efficiency, fluid resistance, and flammability data to meet the standards. So what standards will medical surgical masks have? The FDA requires medical masks to provide the following test ...

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This was authorized by the United States FDA on April 3rd, 2020 in an effort to combat the Coronavirus. To be allowed to sell in the United States healthcare market a manufacturer must be certified which includes registration with the FDA in America and additional 3rd party certifications (Not just China certification).

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