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Medical Surgical 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(s), provided non-sterile.

Medical Surgical Masks are disposable medical masks and are made of mask body, nose clips and mask belt by ultrasonic heat sealing. The mask body is divided into three layers: inner, middle and outer layers, the inner and outer layers are Non-woven fabrics and middle layer is polypropylene melt blown cloth, nose piece is made of galvanized iron wire covered plastic materials. The mask belt is made of spandex. The mask style is flat pleated.

Here's an analysis of the acceptance criteria and study proving the device meets them, based on the provided FDA 510(k) summary for the "Medical Surgical Mask":

The document does not describe a clinical study in the traditional sense for evaluating the device's performance with human patients or AI assistance. Instead, it describes non-clinical performance testing (bench testing) to demonstrate that the device meets established safety and performance standards for surgical masks.

Acceptance Criteria and Reported Device Performance

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