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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 FINGERS TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.

DISPOSABLE POWDERED VINYL EXAM GLOVES

This document is a 510(k) premarket notification letter for Disposable Powdered Vinyl Exam Gloves. It confirms that the device is substantially equivalent to legally marketed predicate devices.

This document does not contain information about acceptance criteria or a study that proves the device meets acceptance criteria. It is a regulatory clearance letter, not a performance study report. Therefore, I cannot extract the requested information.

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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 FINGERS TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.

DISPOSABLE POWDERED VINYL EXAM GLOVES

The provided text is a 510(k) premarket notification approval letter for "Disposable Powdered Vinyl Examination Gloves". This document does not contain information about acceptance criteria or a study proving device performance in the context of an AI/ML device. Therefore, I cannot generate the requested table and study details.

The document is a regulatory approval for a medical device and focuses on its substantial equivalence to a legally marketed predicate device, rather than detailed performance metrics and studies that would be associated with an AI/ML product.

Ask a specific question about this device