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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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Powdered 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.

powdered vinyl patient examination gloves, Clear(non-colored) that meets all of the requirements of ASTM standard D 5250-004

Here's an analysis of the provided information, focusing on acceptance criteria and supporting studies for the device:

Device: Powdered Vinyl Patient Examination Gloves, Clear (Non-colored)
510(k) Number: K062520

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, Clear(non-colored) that meets all of the requirements of ASTM standard D 5250-00-4.

The provided text describes a submission for a medical device, specifically "Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)," rather than a complex AI-powered diagnostic device. Therefore, many of the requested categories (e.g., sample size for test sets, number of experts for ground truth, MRMC study, training set details) are not applicable as they relate to studies of diagnostic accuracy, which are not performed for basic medical devices like gloves.

Here's an analysis based on the provided text for the aspects that are applicable:

1. Table of Acceptance Criteria and Reported Device Performance

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