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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 5250-00-4

Here's an analysis of the provided text regarding the acceptance criteria and study for the ZIBO HENGDE PLASTIC&RUBBER PRODUCTS CO.,LTD Powdered Vinyl Patient Examination Gloves (K070008):

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 5250-000

The provided document describes the acceptance criteria and performance of "Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)" and not an AI/ML device. Therefore, many of the requested categories for AI/ML device evaluation are not applicable.

Here's the information that can be extracted from the provided text regarding the glove's acceptance criteria and how its compliance was demonstrated:

1. Table of Acceptance Criteria and Reported Device Performance

Ask a specific question about this device