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Jian Yu surgical mask is intended to be worn to protect both patients and healthcare workers from transfer of microorganisms, body fluids, and particulate material. The surgical mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. The JianYu surgical mask is a single use, disposable device provided non-sterile.

The JianYu surgical mask is composed of 3-layers and is flat-pleated. The mask materials consist of an outer layer (spunbond polypropylene, blue), filter layer (meltblown polypropylene, white), and inner layer (spunbond polypropylene, white). The three layers of the mask body are collated and sonically welded around the edges. The surgical mask contains ear loops attached by welding to secure the mask over the user's mouth and face and includes a malleable nosepiece to provide a firm fit over the nose. The surgical mask is a single use, disposable device, provided non-sterile.

The manufacturer, Jiangsu JianYu Health Medical Co., Ltd., submitted a 510(k) premarket notification (K201754) for their JianYu Surgical Mask. The device is classified as a Class II surgical apparel under regulation 21 CFR 878.4040. The predicate device is the "Surgical Face Mask (EL30000)" cleared under K160269.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the JianYu Surgical Mask are based on the ASTM F2100-19 Level 3 standard for medical face mask performance. The reported performance of the device is compared against these criteria, as well as against the predicate device (K160269).

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