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The non-sterile disposable medical 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 sterile disposable medical face masks are intended for single use by operating room personnel and other general healthcare workers to protect both patients and healthcare workers against transfer of microorganisms, blood and body fluids, and particulate materials.

The proposed device. Disposable medical face masks, is provide in sterile and non-sterile two types.

Both the non-sterile disposable medical face masks and sterile disposable medical face masks are available in five sizes, which are 95mm×155mm, 95mm×140mm, 95mm×145mm and 95mm×160mm. And both the non-sterile disposable medical face masks and sterile disposable medical face masks are available in two ear strap types, Type A, which is ear-loop type, and Type B, which is tie-on type.

This document describes a 510(k) premarket notification for "Disposable Medical Face Masks" (K202719) by Jiangxi Sanxin Medtec Co., Ltd. The submission aims to demonstrate substantial equivalence to legally marketed predicate devices.

Here's an analysis of the acceptance criteria and supporting studies, based on the provided text:

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Disposable Medical Face Masks are based on Level 2 requirements of the ASTM F2100:2019 standard. The study demonstrates that the proposed device meets these requirements.

Table of Acceptance Criteria and Reported Device Performance:

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