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

Nitrile Examination Gloves, Powder Free

This is an FDA 510(k) clearance letter for Nitrile Examination Gloves, Powder Free. It's a regulatory document, not a scientific study report. Therefore, it does not contain the detailed information required to describe acceptance criteria and a study proving device performance as requested in the prompt.

The document states that the device is "substantially equivalent" to legally marketed predicate devices. This determination is based on a comparison to existing devices, and typically for Class I devices like examination gloves, performance testing is done to demonstrate that the new device meets established standards or is equivalent to the predicate device. However, the details of such testing (acceptance criteria, specific study designs, sample sizes, ground truth) are not included in this clearance letter.

Therefore, I cannot provide the requested information from this document.

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A medical glove is worn on the hand(s) of health care and similar personnel To prevent contamination between heatlh care personnel and the patient.

LATEX EXAMINATION GLOVE, POWDER-FREE

This document is a 510(k) clearance letter from the FDA for "Latex Exam Gloves 50 mcgm or Less of Total Water Extractable Protein Per Gram" by Shun Thai Rubber Gloves Company, Limited, dated November 24, 1998. It primarily deals with the regulatory approval for a medical device and does not contain detailed information about acceptance criteria or specific study results that would typically be found in a clinical study report or performance evaluation.

Therefore, I cannot extract the requested information as it is not present in the provided text. The document confirms that the device is "substantially equivalent" to predicate devices based on its indications for use, but it doesn't provide the specifics of the performance criteria or the study data used to demonstrate that equivalence.

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