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A patient examination gloves 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.

Powder Free Vinyl Synthetic Examination Gloves, White Color (Sensi-Pro)

I am sorry, but the provided text does not contain the information requested in your prompt. The document is a 510(k) clearance letter from the FDA for "Disposable Powder Free Vinyl Synthetic Examination Gloves White Color (Sensi-Pro)". It establishes the device's substantial equivalence to previously marketed devices and outlines regulatory compliance.

The document does not describe:

• Any acceptance criteria for device performance.
• Any study proving acceptance criteria.
• Sample sizes for test sets or training sets.
• Data provenance, expert qualifications, or ground truth establishment.
• Any multi-reader multi-case studies or standalone algorithm performance.

Therefore, I cannot fulfill your request based on the provided input.

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A Medical disposable gloves is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and patient.

Disposable Powder Free Vinyl Synthetic Examination Gloves, White color (Sensi-Pro)

The provided text is a 510(k) clearance letter from the FDA for medical examination gloves. It does not contain information about acceptance criteria or a study proving that a device meets such criteria. The document is strictly a regulatory approval letter.

Therefore, I cannot extract the requested information as it is not present in the given text.

Ask a specific question about this device