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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.

Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) that meets all of the requirements of ASTM standard D 5250-06e1.

The provided document is a 510(k) summary for "Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)". This is a medical device, but it is not an AI/ML powered device, nor is it a device that requires image analysis or complex diagnostic algorithms. Therefore, many of the requested criteria such as "test set", "training set", "experts", "ground truth", "adjudication method", and "MRMC comparative effectiveness study" are not applicable to this type of regulatory submission. The submission is for a physical product, a glove, and its performance is assessed against physical and chemical standards.

Here's a breakdown of the applicable information:

1. Table of Acceptance Criteria and Reported Device Performance

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Powdered 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.

Powdered Vinyl Patient Examination Gloves, Clear (non-colored) that meets all of the requirements of ASTM standard D 5250-06e1.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

Device: Powdered Vinyl Patient Examination Gloves, Clear (non-colored)

1. Table of Acceptance Criteria and Reported Device Performance

Ask a specific question about this device