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Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

The subject device is disposable medical PVC gloves that made from PVC compound, Clear (non-colored), powder free and nonsterile. The device meets the specifications in ASTM D5250-06(Reapproved 2015) Standard specification for poly (vinyl chloride) gloves for medical application.

This document is a 510(k) Premarket Notification summary for "Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)". It describes the device, its intended use, and the studies conducted to demonstrate substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

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Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

PVC films form a barrier to body fluids and bloodborne Pathogens. The PVC rubber is water tight under normal conditions of use. Its tensile properties cause it to conform to the hand, allowing movements necessary for a medical procedure. Poly (vinyl chloride) glove is known to create a barrier to bloodborne pathogens and body fluids. ASTM conforming tensile properties create a glove that is strong and flexible. The glove is manufactured in accordance with the requirements of ASTM D5250 and ASTM D5151 requirements.

The provided text details the 510(k) summary for "Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)". This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study description of an AI-powered device. Therefore, much of the requested information regarding AI device studies (like sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for AI) is not applicable or present in this document.

However, I can extract the acceptance criteria and reported device performance for these medical gloves:

1. Table of Acceptance Criteria and Reported Device Performance:

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Powdered Free Vinyl Patient Examination Gloves, Clear (non-colored) is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Powdered Free Vinyl Patient Examination Gloves, Clear (non-colored) are disposable devices which made of PVC material .intended for medical purpose that worn on examiner's hand or finger to prevent contamination between patient and examiner and they meets all of the requirements of ASTM standard D 5250-06 e1.

The provided document describes the acceptance criteria and performance of "Powdered Free Vinyl Patient Examination Gloves, Clear (non-colored)" manufactured by Hongxin Plastic Products Co.,Ltd. It's important to note that this is a medical device (gloves), not an AI algorithm, so many of the questions related to AI studies (like MRMC studies, training sets, expert ground truth for imaging, etc.) are not applicable.

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Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

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