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  • Description: Approvals Required to Meet Requirement of Face Mask & 0183;32;These face masks, respirators and other PPE kit must meet the definition of a device under section 201(h) of the FD& C Act, i.e. expanded as Federal Food, Drug, and Cosmetic Act. Usually, face masks come under the radar of this definition when they get intended for a medical need, including for health care professionals use.

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    Surgical Masks U.S. Food and Drug Administration

    This guidance represents the Food and Drug Administration's (FDA's) current thinking on this topic. Surgical masks include parts that have prolonged contact with intact skin. We recommend that

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    Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus; 6 406 ASTM F1862/F1862M 17 Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity)

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    The N95 respirator is the most common of the seven types of particulate filtering facepiece respirators. This product filters at least 95% of airborne particles but is not resistant to oil. This web page provides a table of NIOSH approved N95 respirators, listed alphabetically by manufacturer.

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    How Surgical Masks are Made, Tested and Used

    Minimum protection face masks are meant for short procedures or exams that wont involve fluid, spray, or aerosol. Level 1 face masks often feature ear loops and are the general standard for both surgical and procedural applications, with a fluid resistance of 80 mmHg. Theyre meant for low risk situations where there will be no fluid

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    Respiratory protection certification PPE.ORG

    This article on respiratory protection certification is specific to the Respiratory Protection category of PPE, and should be read in conjunction with the article on product testing and PPE CE marking.It sets out to provide an explanation of the mandatory European Legislative requirements to

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