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A powdered patient examination glove is a disposable device made of natural rubber latex that bears powder to facilitate donning and is intended to be worn on the hand or finger (s) for medical purposes to provide a barrier against potentially infectious materials and other contaminants.

Powdered Latex Examination Gloves, Non-sterile

This document is a 510(k) clearance letter from the FDA for "Multisafe Powdered Latex Examination Gloves, Nonsterile." It does not contain any information regarding acceptance criteria, study details, or device performance metrics like sensitivity, specificity, or accuracy that would be relevant to AI/ML medical devices.

The letter is a regulatory document confirming that the device is substantially equivalent to legally marketed predicate devices and can be marketed. It refers to general controls, GMP regulations, and labeling requirements.

Therefore, it is impossible to extract the requested information (acceptance criteria, study details, sample sizes, ground truth, expert qualifications, etc.) for an AI/ML device from this document.

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