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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 prevent contamination between patient and examiner. 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. The Poly (vinyl chloride) glove acts as a barrier to prevent contamination between patient and examiner. The glove is manufactured in accordance with the requirements of ASTM D5250 and ASTM D5151.

The provided text is an FDA 510(k) summary for "Kindguard Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)". This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving a medical device's performance against specific clinical efficacy or diagnostic accuracy criteria as would be required for a novel AI/imaging device.

Therefore, many of the requested categories (e.g., sample size for test/training set, number of experts, adjudication methods, MRMC studies, effect size, type of ground truth) are not applicable to this type of medical device submission. This submission relies on established performance standards for examination gloves.

Here's how the available information from the document applies to your request:

1. Table of Acceptance Criteria and Reported Device Performance:

The document compares the subject device's performance against established ASTM standards and FDA requirements, as well as against the predicate device.

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Kindguard Powder Free Vinyl Patient Examination Gloves, Light Yellow Color 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.

PVC films form a barrier to prevent contamination between patient and examiner. The PVC rubber is water tight under normal conditions of use. It's tensile properties cause it to conform to the hand, allowing movements necessary for a medical procedure. The Poly (vinyl chloride) glove acts as a barrier to prevent contamination between patient and examiner. The glove is manufactured in accordance with the requirements of ASTM D5250 and ASTM D5151.

The provided document describes a 510(k) premarket notification for Kindguard Powder Free Vinyl Patient Examination Gloves. This is a Class I medical device, and the evaluation for substantial equivalence primarily relies on non-clinical performance data and comparison to a predicate device, rather than a study involving an AI algorithm or human readers.

Therefore, many of the requested elements for describing the acceptance criteria and the study that proves the device meets those criteria (especially those related to AI, human readers, ground truth establishment, sample sizes for training/test sets, and expert adjudication) are not applicable to this type of device and submission.

However, I can extract the relevant information regarding the acceptance criteria and the performance of this specific device based on the provided text.

Here's a breakdown of the requested information, with NA (Not Applicable) for elements not relevant to this submission type:

Acceptance Criteria and Device Performance for Kindguard Powder Free Vinyl Patient Examination Gloves

This submission is for a Class I medical device (patient examination gloves), which does not involve an AI algorithm or complex human interpretation tasks. Thus, the "study" proving acceptance is primarily a set of non-clinical performance tests and a comparison to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance:

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