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

Powder Free Synthetic Vinyl Patient Examination Gloves, White

This document (K031170) is a 510(k) premarket notification decision letter from the FDA for a medical device. It does not contain information about the acceptance criteria or a study proving that the device meets those criteria.

The acceptance criteria typically refer to performance metrics (e.g., sensitivity, specificity, accuracy) that a medical device must achieve in a clinical study to be considered safe and effective for its intended use. This document is a regulatory approval notice, indicating that the device is substantially equivalent to legally marketed predicate devices, not a study report.

Therefore, I cannot extract the requested information from the provided text.

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