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The Premier Guard USA 3 Layer Ear Loop ASTM Level 3 Surgical Face 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, provided non-sterile.

The Premier Guard Face Mask is a flat-pleated style mask with elastic ear loops to secure it over the users' mouth and face. The mask consists of three-layers. The inner facing layer is white and is manufactured from spunbond polypropylene (three layers of nonwoven polypropylene). The inner filter material is made of meltblown fiber. The outer facing layer is blue and is manufactured from spunbond polypropylene (three layers of nonwoven polypropylene). The mask is a single use, disposable device, provided non-sterile. The proposed device is not made from natural rubber latex.

The provided text presents a 510(k) summary for a surgical face mask, focusing on non-clinical performance and biocompatibility testing. It does not describe a study involving an AI/software device or human readers. Therefore, I cannot extract the information required for questions pertaining to AI performance, human reader improvement with AI assistance, MRMC studies, or multi-expert ground truth establishment.

However, I can provide information based on the presented non-clinical performance testing of the Premier Guard USA 3 Layer Ear Loop ASTM Level 3 Surgical Face Mask.

Here's the information that can be extracted from the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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