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BRIGHTWAY™ Brand Latex Examination Glove, Powder Free containing 50 µgm or less of water extractable protein per gram is a disposable patient examination glove which is worn on the hand of healthcare and similar personnel to prevent contamination between patient and examiner.

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This document is a 510(k) premarket notification approval letter for "Brightway™ Brand Latex Examination Gloves Powder-Free." It does not contain information about acceptance criteria or a study that proves the device meets those criteria, as it is a regulatory approval document rather than a study report.

Therefore, I cannot provide the requested information based on the provided text. The document primarily confirms that the device is substantially equivalent to legally marketed predicate devices and outlines regulatory responsibilities.

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