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When properly worn, the Ear-Friendly Masks are intended to protect and healthcare workers from transfer of microorganisms, body fluids and particulate material. This device is non sterile and for single use only.

The Ear-Friendly Masks are non-sterile, single use, 3 layers, flat-pleated style with ear loops and nose piece. The outer layer and inner facing layer of face mask consist of Spunbond Polypropylene, and the middle layer consists of Melt Blown Polypropylene Filter. Each mask contains ear loops to secure the mask over the user's face and mouth with nose piece to firmly fit over the nose. This device is not made from any natural rubber latex.

Here's a breakdown of the acceptance criteria and study that proves the device meets them, based on the provided FDA 510(k) Summary for the "Ear-Friendly Mask."

Device Description:
The Ear-Friendly Mask is a non-sterile, single-use, 3-layer, flat-pleated surgical face mask with ear loops and a nose piece. It is intended to protect both patients and healthcare workers from the transfer of microorganisms, body fluids, and particulate material.

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Ear-Friendly Mask are based on the ASTM F2100 standard for the performance of materials used in surgical face masks, specifically for Level 3 performance. The table below outlines the acceptance criteria and the device's reported performance:

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