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According to 21 CFR, a 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.

POWDER FREE LATEX PATIENT EXAMINATION GLOVES

I am sorry, but the provided text does not contain the necessary information to answer your request. The document is an FDA 510(k) clearance letter for "POWDER FREE LATEX PATIENT EXAMINATION GLOVES" and does not detail acceptance criteria or a study that proves the device meets such criteria. It primarily addresses the regulatory approval of the gloves based on substantial equivalence.

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According to 21 CFR, 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.

PRE POWDERED LATEX PATIENT EXAMINATION GE

The provided text is a 510(k) premarket notification approval letter for a medical device: "PRE POWDERED LATEX PATIENT EXAMINATION GE" (likely "Glove"). This type of document is a regulatory approval, not a scientific study report. It states that the device is "substantially equivalent" to legally marketed predicate devices.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria. The information requested (such as sample size, ground truth, expert qualifications, adjudication methods, and details of standalone or MRMC studies) is typically found in clinical trial reports or detailed performance studies, which are not part of this 510(k) approval letter.

The primary "acceptance criterion" for a 510(k) submission is demonstrating substantial equivalence to a predicate device, which is what this letter confirms. However, specific performance metrics and a study to prove they are met are not detailed here.

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