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A powder free nitrile surgical glove is a disposable device intended to be worn on the hands by operating room personnel to provide a barrier against potentially infectious materials and other contaminants.

Sterile Powder Free Nitrile Surgical Gloves

I'm sorry, but based on the provided text, I cannot describe the acceptance criteria and the study that proves the device meets those criteria. The provided document is a 510(k) clearance letter from the FDA for Sterile Powder Free Nitrile Surgical Gloves. It confirms that the device is substantially equivalent to legally marketed predicate devices and outlines the regulatory framework.

The document does not contain any information about:

• Specific acceptance criteria for device performance (e.g., tensile strength, puncture resistance, barrier integrity metrics).
• Any studies conducted to demonstrate the device meets acceptance criteria.
• Sample sizes for test sets, data provenance, ground truth establishment, expert qualifications, or adjudication methods.
• Information regarding multi-reader multi-case studies or standalone algorithm performance.

Therefore, I cannot provide the requested information.

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A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. Gloves that have been tested for use with chemotherapy drugs are not intended to be used as a chemical barrier.

Powderfree Blue Latex Examination Gloves – Tested For Use With Chemotherapy Drugs; Powderfree Natural Latex Examination Gloves - Not Tested For Use With Chemotherapy Drugs

This document is a 510(k) premarket notification letter from the FDA regarding patient examination gloves. It does not contain information about the acceptance criteria or a study proving that a device meets such criteria. Therefore, I cannot answer your request based on the provided text.

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