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The Nitrile Examination Glove (Powder free, Blue) is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.

The proposed device, Nitrile Examination Glove (Powder free, Blue) are disposable devices intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.

The proposed devices are Powder Free Nitrile Examination Gloves and includes variations of different size. The color of the proposed device is Blue.

The proposed device is not provided as sterilized The proposed device is made of Nitrile.

This document is a 510(k) Pre-market Notification for a medical device, specifically a Nitrile Examination Glove. The purpose of this notification is to demonstrate substantial equivalence to a legally marketed predicate device. The information provided outlines the acceptance criteria and the results of non-clinical tests to prove the device meets these criteria.

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

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

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