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A Patient Examination Glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Powdered Nitrile Examination Gloves (Blue Colour)

The provided document is an FDA 510(k) clearance letter for "Powdered Nitrile Examination Gloves (Blue Colour)." This type of document is a regulatory approval, not a technical report detailing performance criteria or a study. Therefore, it does not contain the information requested in the prompt regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment for a device's performance.

The letter explicitly states: "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976..." This indicates a regulatory comparison to a legally marketed predicate device, not a new performance study with specific acceptance criteria as you've outlined.

Therefore, I cannot provide the requested information from this document.

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A Patient Examination Glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Powdered Patient Nitrile Examination Gloves (Blue Colour)

The provided document is a 510(k) premarket notification letter from the FDA regarding "Powdered Nitrile Examination Gloves (Blue Colour)". It confirms that the device is substantially equivalent to legally marketed predicate devices.

**This document does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details for an AI/ML powered device. **

The letter is a regulatory approval for a physical medical device (gloves), not an AI/ML software device, and therefore the requested information is not applicable to its contents.

Ask a specific question about this device