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The Surgical Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. The medical surgical 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 proposed surgical masks are blue color, three-layer, flat-pleaded masks with nose piece, ear loops or ties, which are composed of inner layer, middle layer and outer layer, with or without anti-fog foam strips and eye shield. The outer layers contains blue colorant and the inner layer contains white colorant, which are made of polypropylene.

Below are the configuration of each model.

GFM 96 - three-layer, flat-pleated with ear loops

GFM 91 - three-layer, flat-pleated with ear loops and anti-fog foam strip attached to nose clip

GFM 90 - three-layer, flat-pleated with ear loops, anti-fog foam strip attached to nose clip and eye shield

GFM 88 - three-layer, flat-pleated with ties

GFM 81 - three-layer, flat-pleated with ties and anti-fog foam strip attached to nose clip

GFM 80 - three-layer, flat-pleated with ties, anti-fog foam strip attached to nose clip and eye shield

The inner layer and outer layer of the mask are made of spunbond polypropylene, the middle layer is made of melt-blown polypropylene. The ear loops or ties of the subject mask are held in place over the users' mouth and nose by two ear loops or ties welded to the face mask. The ear loop is made with polyester and spandex, while the ties are made of spunbond polypropylene. The nose piece in the layers of face mask is to allow the user to fit the mask around their nose, which is made of PP and metal.

The masks may also contain an eye shield made from a polyethylene terephthalate film (PET) with foam strip. The eye shield is adhered to the top edge of the mask to cover the upper part of the eye to prevent potential exposure to blood and body fluids.

The surgical masks are sold non-sterile and are intended to be single use, disposable devices.

The masks are designed and manufactured in accordance with ASTM F2100-19 Standard Specification for Performance of Materials Used in Medical Face Masks.

This document is a 510(k) Premarket Notification for a Surgical Mask, specifically models GFM 96, GFM 91, GFM 90, GFM 88, GFM 81, and GFM 80, manufactured by Jingzhou Haixin Green Cross Medical Products Co., Ltd.

The purpose of this submission is to demonstrate that the new device is substantially equivalent to a legally marketed predicate device (K210147). The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the performance standards and non-clinical testing conducted to show the device meets specific requirements for surgical masks and is equivalent to the predicate.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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