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The Powder Free Nitrile Examination Glove is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.

The proposed device, Powder Free Nitrile Examination Glove is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.

The proposed devices are Powder Free Nitrile Examination Gloves and include variations of different sizes from X-Small to X-large. The color of the proposed device is Blue and Indigo

The proposed device is not provided as sterilized The proposed device is made of Nitrile.

The provided document is a 510(k) Pre-Market Notification for a Powder Free Nitrile Examination Glove. The document focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing, rather than a study proving the device meets acceptance criteria for an AI/CADe system. Therefore, I cannot provide details related to AI/CADe specific criteria such as ground truth, expert adjudication, or MRMC studies.

However, I can extract the acceptance criteria and reported device performance for the glove itself, based on the non-clinical tests described in Section 8.0, "Summary of Non-Clinical Testing."

Here is the requested information for the medical glove, structured as closely as possible to your prompt, while acknowledging the limitations of the provided document for AI/CADe specific questions:

1. A table of acceptance criteria and the reported device performance

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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.

PVC films form a barrier to body fluids and bloodborne Pathogens. 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. 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 document describes the acceptance criteria and the study that proves Daxwell, LLC's Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) meet those criteria, primarily through a comparison to a predicate device and adherence to established ASTM and ISO standards.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

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