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A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Powder-free Nitrile Patient Examination Glove, White (non-colored), Blue and Green Colored

The provided text is a 510(k) premarket notification letter from the FDA regarding a Powder-Free Nitrile Patient Examination Glove. This document confirms that the device is substantially equivalent to a predicate device already on the market and does not require an approval for a premarket approval application (PMA).

The document does not detail any studies, acceptance criteria, or performance metrics for the device. It is a regulatory letter of approval based on the substantial equivalence principle, rather than a report on device performance testing. As such, I cannot provide the requested information from the given text.

The information I can extract directly from the provided text is:

• Device Name: Powder-Free Nitrile Patient Examination Glove, White (non-colored), Blue and Green Colored
• Intended Use: A disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
• Regulatory Class: I
• Product Code: LZA
• Regulation Number: 880.6250 (Patient Examination Gloves)

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