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This glove is disposable and intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

Polymer Coated, Powder Free, Nitrile Examination Gloves, Blue Color

This document is a 510(k) clearance letter from the FDA for medical gloves. It does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria. The document only confirms that the specified polymer-coated, powder-free, nitrile examination gloves from PT. Smart Glove Indonesia are substantially equivalent to a legally marketed predicate device.

Therefore, I cannot provide the requested information based on the given text.

The provided text focuses on the regulatory clearance process for a medical device (examination gloves) by the FDA. It does not contain the technical details of device performance, acceptance criteria, or study methodologies that would be needed to answer your specific questions.

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