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The Disposable Medical Face Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. The Disposable Medical Face Mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This a single use, disposable device(s), provided non-sterile.

The Disposable Medical Face Mask is blue color, single use, flat-folded masks with nose piece and ear loops. The blue colorant is polypropylene (PP) master batch.

The body of the mask is composed of three layers: the inner (3rd layer) and outer (1st layers are made of spun-bond polypropylene, the middle (2nd layer) is made of melt blown polypropylene. The nose piece is made of Iron core coated with polypropylene, ear loop is made of Nylon and Spandex.

Each mask contains ear loops to secure the mask over the user's face and mouth with a bendable nose piece to firmly fit over the nose. This device is not made with natural rubber latex.

The Disposable Medical Face Masks are sold and are intended to be single use, disposable devices.

The mask is designed and manufactured in accordance with ASTM F2100-23 Standard Specification for Performance of Materials Used in Medical Face Masks.

This document is a 510(k) Premarket Notification for a Disposable Medical Face Mask (M643BE). It details the non-clinical testing performed to demonstrate substantial equivalence to a predicate device.

Here's the breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. A table of acceptance criteria and the reported device performance:

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