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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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The Surgical Isolation Gown is intended to protect health care personnel from the transfer of microorganisms, body fluids and particulate material. Not intended for use in the operating room. In addition, the Surgical Isolation Gown meets the requirements of an AAMI Level 3 barrier protection for an isolation gown per ANSI/AAMI PB70:2012 Liquid Barrier Performance and Classification of Protective Apparel Drapes Intended for Use in Health Care Facilities (ANSI/AAMI PB70).The Surgical Isolation Gown is a single use, disposable medical nonsterile.

The proposed SURGICAL Isolation Gown is constructed of polyolefin (Polypropylene) SMS nonwoven material with the color in yellow. The SURGICAL Isolation Gowns consist of a one critical zone throughout the entire gown including seams but excluding cuffs, hems, and bindings. The product has been tested for barrier performance per ANSI/AAMI PB70:2012. Testing was performed according to the Guidance on Premarket Notification [510(k)] Submissions for Surgical Gowns and Surgical Drapes, issued on August 1, 1993 and ANSI/AAMI PB70:2012 Liquid Barrier Performance and Classification of Protective Apparel and Drapes Intended for Use in Health Care Facilities. All results of testing met AATCC-42/AATCC-127, and meets AAMI PB70:2012 Level 3 requirements.

This document is a 510(k) premarket notification for a Surgical Isolation Gown. It aims to demonstrate substantial equivalence to a predicate device. Here's an extraction of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the device are largely based on meeting AAMI Level 3 barrier protection requirements as per ANSI/AAMI PB70:2012 Liquid Barrier Performance and Classification of Protective Apparel and Drapes Intended for Use in Health Care Facilities, and demonstrating biocompatibility.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample size for each performance test. However, for "Liquid Barrier Performance Classification Properties" for the proposed device, it mentions that "The critical zone areas tested were the chest, the back, the sleeve seam, the belt seam and side seam."

The data provenance is from non-clinical testing performed by Jingzhou Haixin Green Cross Medical Products Co., Ltd in China, as indicated by the applicant's address. The data is retrospective in the sense that these tests were conducted to support the 510(k) submission, not as a prospective clinical study involving human subjects.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This document describes a medical device (surgical gown) and its physical and barrier properties. It relies on standardized testing protocols (like ANSI/AAMI PB70:2012, AATCC, ASTM, ISO) rather than expert-derived ground truth from imaging or clinical data. Therefore, the concept of "experts establishing ground truth" in the way it applies to diagnostic algorithms is not applicable here. The "ground truth" is established by the specified test methods and their performance criteria.

4. Adjudication Method for the Test Set

Not applicable. The tests are objective physical and chemical measurements based on industry standards, not subjective interpretations requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

Not applicable. This is a submission for a physical medical device (surgical gown), not an AI/software as a medical device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is a submission for a physical medical device (surgical gown), not an AI/software as a medical device.

7. The Type of Ground Truth Used

The "ground truth" for the device's performance is defined by the standardized test methods and their predetermined acceptance criteria (e.g., AAMI Level 3 specifications for barrier performance, Class I for flammability, non-cytotoxic/non-irritating/non-sensitizing for biocompatibility).

8. The Sample Size for the Training Set

Not applicable. As this is a physical medical device, there is no "training set" in the context of machine learning or AI.

9. How the Ground Truth for the Training Set Was Established

Not applicable. There is no training set for this type of device submission.

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