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The Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (White) is a non-sterile disposable device intended for medical purposes that is worn on examiner's hand to protect contamination between patient and examiner

Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (White)

I am sorry, but the provided text from the FDA letter does not contain the detailed information necessary to answer your request regarding the acceptance criteria, study details, and performance of a medical device.

The document is a 510(k) clearance letter for the "Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (White)". This letter confirms that the device is substantially equivalent to a predicate device and can be marketed. It lists the regulation number, product code, and indications for use.

However, it does not include any information about:

• Specific acceptance criteria for device performance.
• The study conducted to prove the device meets acceptance criteria.
• Sample sizes for test or training sets.
• Data provenance.
• Number or qualifications of experts.
• Adjudication methods.
• MRMC comparative effectiveness studies or effect sizes.
• Standalone algorithm performance.
• Type of ground truth used.
• How ground truth for a training set (if applicable) was established.

This type of information is typically found in a 510(k) summary or the full 510(k) submission, neither of which is provided in the given text. The FDA clearance letter primarily states the regulatory decision based on that submission.

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