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A Non-Sterile Nitrile powder free examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

Nitrile Examination Gloves Powder Free Grey Color Non-Sterile

The provided document is a 510(k) clearance letter from the FDA for Nugard Nitrile Examination Gloves. It does not contain information about acceptance criteria for a medical device's performance, nor does it describe a study proving the device meets specific performance criteria as typically expected for software or AI-powered devices.

Instead, this document indicates that the device (examination gloves) has been found substantially equivalent to legally marketed predicate devices. The "Indications for Use" section (Page 3) briefly describes the purpose of the gloves.

Therefore, I cannot extract the requested information about acceptance criteria and a study from this document, as it is not relevant to the type of information typically found in a 510(k) clearance for examination gloves. The questions you posed (sample size for test/training set, expert qualifications, adjudication method, MRMC study, etc.) are generally applicable to the evaluation of diagnostic algorithms or imaging devices, not to a basic medical device like gloves.

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