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All personal protective equipment (PPE) that is intended for use as a medical device must follow The FDA's regulations and should meet applicable voluntary consensus standards for protection.Medical Gowns | FDASurgical Gowns. A surgical gown is regulated by the FDA as a Class II medical device that requires a 510(k) premarket notification. A surgical gown is a personal protective garment intended to be ce fda hospital virus disposable use protective clothingConsiderations for Selecting Protective Clothing | NPPTL ce fda hospital virus disposable use protective clothingClothing for protection against contact with blood and body fluids. Determination of resistance of protective clothing materials to penetration by bloodborne pathogens Test method using Phi-X174 bacteriophage. Note: These tests are typically conducted on fabrics, but they can be conducted on the garment seams as well.

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