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Powder Free Nitrile Examination Gloves, Blue 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 Examination Gloves, Black 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 Examination Gloves, White 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.
The Powder Free Nitrile Examination Gloves, Violet Blue 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.
The Powder Free Latex Examination Gloves 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.

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This document is a 510(k) premarket notification decision letter from the FDA for examination gloves. It does not contain information about an AI/ML powered medical device, a clinical study with acceptance criteria and device performance. Therefore, I cannot extract the requested information.

The document is for "Powder Free Nitrile Examination Gloves (Blue, Black, White and/or Violet Blue), Powder Free Latex Examination Gloves," which are Class I devices (non-powered patient examination gloves) and do not involve AI. The FDA letter confirms the device is substantially equivalent to legally marketed predicate devices, meaning it has met the regulatory requirements for this type of device.

To provide the requested information, the input text would need to describe a medical device that uses AI/ML and include details about its performance studies.

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