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The Zoupure Nitrile Powder Free Examination Glove is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner.

Zoupure Nitrile Powder Free Examination Glove

This document is a 510(k) clearance letter from the FDA for a medical device: Zoupure Nitrile Powder Free Examination glove.

The information requested in the prompt (acceptance criteria, study details, sample sizes, ground truth, expert qualifications, etc.) is typically found in the summary of safety and effectiveness or performance testing reports accompanying the 510(k) submission, not in the clearance letter itself.

The clearance letter primarily states that the FDA has determined the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed. It does not contain the detailed technical performance data or study specifics of the device.

Therefore, based solely on the provided text, I cannot answer the questions regarding acceptance criteria and the study that proves the device meets them because this information is not present in the document.

The document only provides:

• Device Name: Zoupure Nitrile Powder Free Examination glove
• Regulation Name: Non-Powdered Patient Examination Glove
• Indications for Use: "The Zoupure Nitrile Powder Free Examination Glove is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner."
• Type of Use: Over-The-Counter Use

To find the information requested, one would need to access the full 510(k) submission (if publicly available) or a summary provided by the manufacturer.

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