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A medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between health care personnel and the patient.

OmniGrace Nitrile, Green, Examination Glove, Powder Free, Polymer Coated.

The provided document is a 510(k) premarket notification letter from the FDA for a medical device: "Omnigrace Patient Examination Glove, Trade Name: Nitrile, Green, Powder-Free, Polymer Coated." This letter confirms that the device is substantially equivalent to legally marketed predicate devices.

However, the document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.

The 510(k) clearance process primarily focuses on demonstrating substantial equivalence to a predicate device, rather than requiring extensive clinical efficacy or performance studies with detailed acceptance criteria as one might find for a novel, high-risk device. For devices like examination gloves, the FDA typically assesses factors such as biocompatibility, physical properties (e.g., tensile strength, puncture resistance), and viral barrier claims, often against recognized standards. The letter itself does not detail these specific test results or their acceptance criteria.

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