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The patient examination 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.

Pre-Powdered Vinyl Patient Examination Glove

The provided document is a 510(k) premarket notification letter from the FDA for a Pre-Powdered Vinyl Patient Examination Glove. This product is a Medical Device Class I.

The letter explicitly states that the FDA "reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent... to legally marketed predicate devices."

The determination of substantial equivalence for Class I devices like examination gloves typically involves demonstrating that the new device has the same intended use and technological characteristics as a predicate device, or different technological characteristics that do not raise different questions of safety and effectiveness. This often relies on performance standards rather than extensive clinical studies as would be required for higher-risk devices or novel technologies.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set information is not applicable to this document because it pertains to a simple Class I medical device (patient examination glove) whose substantial equivalence is determined by fulfilling established performance standards for such products, not through clinical trials or complex AI model validation.

The "Indications for Use" section (page 3 of the document) describes the intended purpose of the glove: "The patient examination 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." This is a standard indication for such devices.

The 510(k) clearance process for this type of device typically involves demonstrating compliance with recognized standards for physical properties (e.g., tensile strength, elongation), barrier integrity (e.g., freedom from holes), and biocompatibility, rather than efficacy studies involving human subjects or AI model performance.

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