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A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner hands or fingers to prevent contamination between patient and examiner.

Powderfree patient latex examination gloves, with protein label claim ( 50 micrograms or less of total water extractable protein per gram.)

This document is a 510(k) clearance letter from the FDA for medical gloves. It does not contain information about the acceptance criteria or a study proving that a device meets acceptance criteria. It is a regulatory approval document for a medical device (gloves), not a performance study report for an AI/ML device. Therefore, I cannot extract the requested information from the provided text.

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A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner hands or fingers to prevent contamination between patient and examiner.

Powderfree( Polymer coated ) patient latex examination gloves

The provided text is a 510(k) premarket notification letter from the FDA regarding "Southland Powder-Free (Polymer-Coated) Latex Examination Gloves." This document does not contain any information about acceptance criteria or studies that prove the device meets acceptance criteria.

The letter confirms that the device is substantially equivalent to legally marketed predicate devices and can be marketed subject to general controls. It mentions the product code (LYY) and regulatory class (I), and states the indications for use.

Therefore, I cannot provide the requested information.

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