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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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Powdered Free Vinyl Patient Examination Gloves, Light Yellow Color 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, Light Yellow Color that meets all of the requirements of ASTM standard D 5250-06e1.

This section describes acceptance criteria and the study proving the device meets said criteria.

The device under consideration is "Powdered Free Vinyl Patient Examination Gloves, Light Yellow Color."

1. Table of Acceptance Criteria and Reported Device Performance:

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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.

Powder Free Vinyl Patient Examination Gloves, Light Yellow Color that meets all of the requirements of ASTM standard D 5250-06e1.

The provided text describes the acceptance criteria and performance of "Powder Free Vinyl Patient Examination Gloves, Light Yellow Color." This is a Class I medical device, and the study described is a non-clinical assessment against established standards, not a study of an AI-powered device. Therefore, many of the requested fields related to AI, such as "multi reader multi case (MRMC) comparative effectiveness study," "standalone (i.e. algorithm only without human-in-the loop performance)," "training set," and "adjudication method," are not applicable.

Here's the information extracted from the document:

1. Table of Acceptance Criteria and Reported Device Performance

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Powder Free Vinyl Patient Examination Gloves, Light Yellow Color 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.

Powder Free Vinyl Patient Examination Gloves, Light Yellow Color that meets all of the requirements of ASTM standard D 5250-06e1.

The provided text describes the acceptance criteria and performance of Powder Free Vinyl Patient Examination Gloves, Light Yellow Color, as submitted in a 510(k) summary (K093570) to the FDA. The study presented a non-clinical evaluation to demonstrate substantial equivalence to a predicate device.

Here's the breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

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Powder free vinyl patient examination glove 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.

powder free vinyl patient examination gloves, (Light Yellow) that meets all of the requirements of ASTM standard D 5250-06.

The provided text describes the 510(k) premarket notification for "Powder Free Vinyl Patient Examination Gloves (Light Yellow)." As such, the information contained does not pertain to the development or validation of a medical AI device. Instead, it details the safety and effectiveness information for a physical medical device (examination gloves) compared to a predicate device.

Therefore, many of the requested sections about AI device validation criteria, such as sample sizes for test and training sets, number of experts for ground truth, adjudication methods, multi-reader multi-case studies, and standalone performance, are not applicable to this document.

Here's an analysis of the available information based on the provided text, focusing on the acceptance criteria and the study (or tests) proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

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