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The Surgical Face Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. The Surgical Face 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 nonsterile.

The Surgical Face Masks are blue color, three-layer, flat-pleaded masks with nose piece and ear loops, which are composed of outer facing layer and inner facing layer. The colorant is blue polypropylene (PP) master batch.

The outer facing layer and inner facing layer of the mask are made of spun-bond polypropylene, the middle layer is made of melt blown polypropylene. The ear loop of the subject mask is held in place over the users' mouth and nose by two ear loops welded to the face mask. The ear loop is made with nylon and spandex. 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 polypropylene wrapped aluminium.

The Surgical Face Mask is sold non-sterile and are intended to be single use, disposable devices.

The mask is designed and manufactured in accordance with ASTM F2100-19 Standard Specification for Performance of Materials Used in Surgical Face Masks.

Please find below the acceptance criteria and study information based on the provided text.

Note: The provided document is a 510(k) Premarket Notification for a Surgical Face Mask. It details performance testing against established standards for physical properties and biocompatibility, not for a software-based AI/ML medical device. Therefore, many of the requested categories (e.g., sample size for test set with data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance with humans, training set details) are not applicable to this type of device and the information is not present in the document. The document focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance and biocompatibility testing.

Acceptance Criteria and Reported Device Performance

1. Table of acceptance criteria and the reported device performance

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The Surgical Face Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. The Surgical Face 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 Surgical Face Masks are blue color, four-layer, flat-pleaded masks with nose piece and ear loops, which are composed of outer facing layer, second facing layer and inner facing layer. The colorant is blue polypropylene (PP) master batch.

The outer facing layer and inner facing layer of the mask are made of spun-bond polypropylene, the second facing layer is made of nylon single way filting net, the middle layer is made of melt blown polypropylene. The ear loop of the subject mask is held in place over the users' mouth and nose by two ear loops welded to the face mask. The ear loop is made with nylon and spandex. 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 polypropylene wrapped aluminium.

The Surgical Face Mask is sold non-sterile and are intended to be single use, disposable devices.

The mask is designed and manufactured in accordance with ASTM F2100-19 Standard Specification for Performance of Materials Used in Surgical Face Masks.

The document describes the acceptance criteria and the results of non-clinical tests for a Surgical Face Mask (HNFM0304) to demonstrate its substantial equivalence to a predicate device (K212097).

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Ask a specific question about this device