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The Disposable Surgical Face Masks are intended to be worn to protect both the patient and healthcare provider 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 bodily fluids. This is a single use, disposable device provided non-sterile.

The KDI Med Supply surgical face mask is with blue outer color layer and white inner and middle layer. Subject device is a flat pleated type mask, utilizing ear loop way for wearing, and it has a nose piece designed for fitting the face mask around the nose. The mask materials consist of an outer layer (polypropylene spunbond), inner layer (polypropylene spunbond), filter (polypropylene melt-blown) and ear-loops. The masks contains a malleable nose piece to provide a firm fit over the nose and to secure the mask over the users mouth and face. The mask has level II fluid resistance under ASTM F2100. The mask is a single use, provided nonsterile. This product contains no components made with natural rubber latex.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text, specifically for the "3 Ply Medical Grade Single Use Procedural Disposable Face Mask (K220637)".

The device is a medical face mask, and its acceptance criteria are based on established standards for such devices. The studies conducted are benchtop performance tests comparing the subject device to a predicate device and evaluating its performance against specific ASTM and ISO standards.

1. Table of Acceptance Criteria and Reported Device Performance

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