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A powder-free patient examination glove is a disposable device made of natural rubber latex material that may bear a trace amount of glove powder and is intended to be worn on the hand or finger(s) for medical purposes to provide a barrier against potentially infectious materials and other contaminants.

A non-sterile, disposable, patient examination glove made of natural rubber latex, powder-free, with or without polymer coating.

The provided document describes the 510(k) summary for the Palm-Pro and Palm-Pro Premium Powder-Free Latex Examination Gloves. These gloves are Class I devices and their acceptance criteria and performance are outlined in relation to established ASTM standards and FDA regulations.

Here's a breakdown of the requested information based on the document:

1. Table of Acceptance Criteria and Reported Device Performance

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