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The Surgical Masks 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 the potential exposure to blood and body fluids. This is a single use, disposable device(s), provided non-sterile/ sterile.

The Surgical Masks are Flat Pleated type mask, utilizing Ear Loops way for wearing, and they all have Nose Piece design for fitting the face mask around the nose. The Face Masks are manufactured with three layers. The outer layer is made of spunbonded polypropylene (PP) non-woven fabric. The middle layer with filtration function is made of melt blown polypropylene (PP) non-woven fabric. The inner layer contact with face is made of polypropylene (PP) fabric. The Surgical Masks are single use, disposable device, provided non-sterile/sterile.

The provided text is a 510(k) Summary for a Surgical Mask (K202354). It details non-clinical performance testing for the device. Clinical studies (multi-reader multi-case, standalone, etc.) were explicitly not part of this submission, as stated in Section VIII: "No clinical study is included in this submission." Therefore, the information regarding expert adjudication, ground truth establishment for a training set, and the specific details of comparative effectiveness studies (MRMC) are not applicable to this submission.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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