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The medical surgical mask are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These 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.

The medical surgical mask is pleated three-layer mask with ear loops and nose piece. The inner and outer layers are made of spun-bond non-woven fabric. The middle layer is made of melt blown non-woven fabric. only the outer layers' color is blue (colorant: Pigment Blue 15:3 /CAS number: 147-14-8), which is held to cover the users' mouth and nose by two spandex elastic bands ultrasonic welded to the medical surgical mask. The elastic ear loops are not made with natural rubber latex. The nose piece contained in the medical surgical mask is in the middle layer of medical surgical mask to allow the user to fit the medical surgical mask around their noses, which is made of malleable aluminum wire coated with plastic materials. The dimensions of each medical surgical mask are length 175±5 mm and width 95±5 mm, The dimensions of nose piece is length 110±20 mm, and the ear loop is length 165±10 mm. The medical surgical mask are sold non-sterile and are intended to be single use, disposable devices.

The document provided pertains to a 510(k) premarket notification for a Medical Surgical Mask. It demonstrates substantial equivalence to a predicate device based on non-clinical performance testing. The device is a "Medical Surgical Mask" (K212867) from Nanchang Kanghua Health Materials Co., Ltd. and its predicate device is "Disposable Surgical Face Mask" (K153496) from Xiantao Rayxin Medical Products Co., Ltd.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

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