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INTAI Surgical Mask is intended to be worn 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. This is a single use, disposable device and provided non-sterile.

The INTAI Surgical Mask is single use, three-layers, flat-pleated masks with ear loops, and nose clip. The inner and outer layers are made of Non-woven fabric (Polypropylene), and the middle filter layer is made of a melt blown fabric (Polypropylene). The ear loops welded are used to keep the mask close to the mouth and the nose. The ear loops are made of Nylon. The nose clip, which is made by plasticity material (HDPE), contained in masks is in the layers of the surgical mask to allow the users to fit the facemask around their nose. The surgical mask are provided in one color (blue), non-sterile and intended to be single use, disposable device.

This document is a 510(k) premarket notification for a medical device, specifically the INTAI Surgical Mask. It details the device's characteristics and its comparison to a legally marketed predicate device to demonstrate substantial equivalence.

Here's an analysis 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

The document presents the acceptance criteria and performance results directly in Table 2: Comparison of Performance testing on page 5 and the subsequent Summary of Non-Clinical Test table on page 6.

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