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The Powder Free Blue Nitrile Examination Glove, Non Sterile 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.

The Powder Free Blue Nitrile Examination Gloves, Non Sterile meets all the requirements of ASTM standard D 6319 -- 00a53 and FDA 21 CFR 800.20.

Here's a breakdown of the acceptance criteria and study information for the WRP Asia Pacific Sdn Bhd's Powder Free Blue Nitrile Examination Gloves, Non-Sterile, based on the provided document:

This document is a 510(k) summary for a medical device (examination gloves), which primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than a comprehensive clinical study report for a novel AI device. Therefore, many of the requested categories for AI/software studies are not applicable.

1. A table of acceptance criteria and the reported device performance

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