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A powdered 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.

The Powdered, Natural Color, Latex Examination Gloves, Non-Sterile meets all the requirements of ASTM standard D 3578-01a22 and FDA 1000 ml Water Leak Test.

This document describes the technical characteristics and performance of "Powdered, Natural Color, Latex Examination Gloves, Non-Sterile" produced by Best Putra Gloves Sdn Bhd. It serves as a 510(k) summary for clearance by the FDA.

1. Acceptance Criteria and Reported Device Performance

The device is assessed against ASTM standard D 3578-01a22 and FDA 1000 ml Water Leak Test. The table below outlines the specific characteristics and their performance:

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