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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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