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A powdered patient examination glove is a disposable device made of nitrile for medical purposes that is worn upon the hand to prevent contamination between patient and examiner.

Sunmax Blue Nitrile Powdered Examination Gloves

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study proving that a device meets those criteria. The text is a 510(k) premarket notification letter from the FDA regarding "Sunmax Blue Nitrile Powdered Examination Gloves." It discusses the substantial equivalence of the gloves to a legally marketed predicate device and confirms that the company can begin marketing them.

The document includes:

• A letter from the FDA approving the 510(k) application (K011717) for the Sunmax Blue Nitrile Powdered Examination Gloves.
• An "Indications For Use Statement" for the gloves, describing them as "a disposable device made for medical purposes to prevent contamination between patient and examiner."

It does not contain:

• A table of acceptance criteria and reported device performance.
• Information on sample sizes, data provenance, or expert qualifications for ground truth.
• Details on adjudication methods, MRMC studies, or standalone algorithm performance.
• Information about training sets or how their ground truth was established.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text.

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