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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.

Vinyl Patient Examination Gloves Powder-Free, Non-Sterile

The provided text is a letter from the FDA regarding the 510(k) premarket notification for "Vinyl Patient Examination Gloves Powder-Free, Non-Sterile." This type of document is a regulatory approval for a medical device and does not contain information about the acceptance criteria or a study proving the device meets those criteria, as requested in your prompt.

The letter confirms that the device is "substantially equivalent" to legally marketed predicate devices, meaning it has similar indications for use and technological characteristics to a device already on the market. The FDA's determination of substantial equivalence does not involve clinical studies with acceptance criteria in the same way modern AI/software as a medical device (SaMD) validations do.

Therefore, I cannot extract the requested information from this document. The prompt asks for details typically found in a clinical validation study report for a software or AI-based medical device, which is not what this document is.

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A patient Examination Powder-Free Chlorinated glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

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This document is a 510(k) clearance letter from the FDA for "Powder-Free Latex Examination Gloves" (K973020). It states that the device is substantially equivalent to legally marketed predicate devices.

However, the provided text does not contain any information about acceptance criteria, device performance, studies conducted, sample sizes, ground truth establishment, or expert involvement. These details are typically found in the 510(k) submission itself, or in supporting documentation, not in the clearance letter.

Therefore, I cannot fulfill your request for the specific information you asked for based on the provided text. The document confirms the regulatory approval of the device but offers no technical specifications or study details.

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