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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 5250-00e4

Here's a breakdown of the acceptance criteria and the study information derived from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The device described is a medical device, specifically Powder-Free Vinyl Patient Examination Gloves, Clear (Non-Colored). The acceptance criteria for such a device primarily revolve around its physical properties, safety, and performance standards.

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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 5250-00ed

Here's an analysis of the provided text regarding the acceptance criteria and the study proving the device meets those criteria:

The document describes a 510(k) premarket notification for "Powdered Vinyl Patient Examination Gloves, Clear (Non-colored)." It focuses on demonstrating substantial equivalence to a predicate device, primarily through non-clinical testing.

1. Table of Acceptance Criteria and Reported Device Performance

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