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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.

Omni Flex Nitrile Examination Glove, Powder Free

I am sorry, but I cannot provide a table of acceptance criteria and reported device performance or other detailed study information based on the provided text. The documents are FDA 510(k) clearance letters and an "Indications For Use Statement" for an "Omni Flex Nitrile Examination Glove, Powder-Free".

These documents do not contain any information about performance studies, acceptance criteria, sample sizes, expert qualifications, ground truth establishment, or comparative effectiveness studies (MRMC).

The provided text primarily focuses on:

• Regulatory Clearance: The FDA's determination that the device is "substantially equivalent" to legally marketed predicate devices.
• Product Information: Device name, applicant, and intended use (as stated in the "Indications For Use Statement").
• Regulatory Requirements: Mention of general controls provisions, potential additional controls for Class II/III devices, and compliance with Good Manufacturing Practice.

To answer your request, I would need a different type of document, such as a clinical study report, a regulatory submission summary that includes performance data, or a publication detailing the device's validation.

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