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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.

STERILE DISPOSABLE VINYL SYNTHETIC EXAM GLOVES, POWDER FREE

The provided text is related to an FDA 510(k) clearance for "Sterile Disposable Vinyl Synthetic Examination Gloves, Powder Free". This document is a clearance letter and an "Indications for Use" statement, not a study report or clinical trial summary.

Therefore, the input does not contain the necessary information to describe acceptance criteria and a study that proves the device meets those criteria. The provided text does not describe:

• Acceptance criteria for device performance (e.g., burst strength, tensile strength, barrier integrity).
• Any specific study conducted to test the device's performance against such criteria.
• Sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment.

This document is solely an administrative clearance from the FDA, stating that the device is substantially equivalent to legally marketed predicate devices for its stated indications for use. It does not contain the detailed technical or clinical study information required to answer the prompt.

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