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The Fluid Resistant Procedure Masks are intended to be worn to protect the patient and healthcare personnel from transfer of microorganisms, blood 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, provided non-sterile.

The Fluid Resistant Procedure 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 Fluid Resistant Procedure Masks are manufactured with three layers. The outer layer is made of spun-bond polypropylene non-woven fabric. The middle layer with filtration function is made of melt blown polypropylene non-woven fabric. The inner layer which contacts with face is made of spun-bond polypropylene non-woven fabric. The Fluid Resistant Procedure Masks are single use, disposable device, provided non-sterile.

The provided document is a 510(k) summary for a Disposable Surgical Mask/Fluid Resistant Procedure Mask. This document describes the device's technical specifications and non-clinical performance testing against established standards to demonstrate substantial equivalence to a predicate device. It does not involve AI or algorithms, so many of the requested categories (like "Number of experts used to establish the ground truth," "Adjudication method," "MRMC study," "Standalone performance," "Training set sample size," and "Ground truth for training set") are not applicable.

Here's the summary of the acceptance criteria and study information found in the document:

1. Table of acceptance criteria and reported device performance:

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