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A Powdered Latex Examination Glove Non Sterile is a disposable device made of natural rubber latex that bears powder to facilitate donning and is intended to be worn on the hand of finger(s) for a medical purpose to provide a barrier againts potentially insfectious material and other contaminations.

The Powdered Latex Examination Gloves, Non Sterile (Contains 200 micrograms or less of Total Water Extractable Protein per dm4) meets all the requirements of ASTM standard D 3578-01 a22 and FDA 1000 ml Water Leak Test.

The provided document outlines the acceptance criteria and performance of a device, but it is not a study in the typical sense of a clinical trial or comparative effectiveness research. Instead, it is a 510(k) Premarket Notification Summary for a medical device (Powdered Latex Examination Gloves, Non Sterile), which aims to demonstrate substantial equivalence to a predicate device.

Here's the breakdown of the acceptance criteria and reported device performance based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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