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The 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 blue nitrile patient examination glove, tested for use with Chemotherapy drugs, that meets all the requirements of ASTM standard D6319, except for sterility requirements.

The provided documentation describes the acceptance criteria and performance of the "Blue Powder Free Nitrile Patient Exam Glove," a Class I medical device. This device is a patient examination glove used to prevent contamination between patient and examiner.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

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