Search Results

This glove is disposable and intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

Powder Free Nitrile Examination Gloves (White, Blue and Purple Color)

I am sorry, but based on the provided document, I cannot extract the information required to answer your request.

The document is an FDA 510(k) clearance letter for "Powder Free Nitrile Examination Gloves." It focuses on the regulatory approval process, substantial equivalence to predicate devices, and the intended use of the gloves.

There is no mention of:

• Acceptance criteria for device performance (other than the implied safety and efficacy for medical gloves).
• Any specific studies proving the device meets acceptance criteria.
• Sample sizes for test or training sets.
• Expert qualifications or ground truth establishment.
• MRMC comparative effectiveness studies or standalone algorithm performance.

Therefore, I cannot populate the table or provide the detailed study information you requested.

Ask a specific question about this device