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A patient examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Powdered Non-Sterile Nitrile Examination Gloves

This document is a 510(k) clearance letter from the FDA for "Powdered Non-Sterile Nitrile Examination Gloves" manufactured by TA CHIA RUBBER IND. CORP. LTD.

It does not describe any acceptance criteria or a study that proves the device meets acceptance criteria. The letter simply states that the FDA has reviewed the 510(k) application and determined the device is "substantially equivalent" to legally marketed predicate devices.

Therefore, I cannot provide the requested information based on the provided text. The document is an administrative clearance, not a study report or a description of performance criteria.

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A patient examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Powder Free Non-Sterile Nitrile Examination Gloves

I'm sorry, but this document does not contain the information requested. The document is an FDA 510(k) clearance letter for patient examination gloves and focuses on regulatory approval rather than a detailed study description with acceptance criteria and performance metrics. Therefore, I cannot extract the specific details about acceptance criteria, study design, expert qualifications, or ground truth establishment that you are looking for.

Ask a specific question about this device