medical gown sale high level apply to u s market

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  • An overview of the medical device industry

    2021-1-13 · 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 worn by health ...

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  • An overview of the medical device industry

    AAMI Level : 4 . Fluid Protection : High fluid and viral protection. Procedures : Orthopedic or other high-movement procedures . Reinforcement : Poly-reinforced. Feature : Breathable sleeve, the outside part of the gown is designed to help prevent glove roll down in surgery. Best for : Cases involving a lot of movement . Size : L, …

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