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The United Sewing High Fluid Resistant Disposable Face Mask, United Sewing High Fluid Resistant Surgical Face Mask and United Sewing High Fluid Resistant Procedure Face Mask are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. These face masks are intended for use in infection control practices to reduce potential exposure to blood and body fluids. These face masks are single-use, disposable devices, provided non-sterile.

The United Sewing High Fluid Resistant Disposable Face Mask is a single use, disposable, nonsterile face mask intended to cover the nose and mouth of the wearer. The subject device consists of 3 layers with the outer and inner layer made with polypropylene spunbound material and middle layer made with polypropylene melt blown material, The device has a bendable nosepiece made with Polyethylene coated single wire, and ear loops made from nylon and spandex material. This device will be provided over the counter under the trade names United Sewing High Fluid Resistant Disposable Face Mask, United Sewing High Fluid Resistant Surgical Face Mask and United Sewing High Fluid Resistant Procedure Face Mask for marketing purpose. This device is not made with natural rubber latex.

The FDA 510(k) summary for K202697 provides detailed acceptance criteria and the results of non-clinical studies for the United Sewing High Fluid Resistant Disposable Face Mask, Surgical Mask, and Procedure Mask.

1. Table of Acceptance Criteria and Reported Device Performance

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