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The Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs - Violet Blue (VBLU) is nonsterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. It is also tested to be used against Chemotherapy Drugs.

Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs -Violet Blue (VBLU)

This document is a 510(k) clearance letter from the FDA for medical examination gloves and does not contain information about an AI-powered medical device or studies related to its performance. Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth.

The document discusses:

• The trade name: Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs - Violet Blue (VBLU)
• Regulation Number: 21 CFR 880.6250
• Regulation Name: Patient Examination Glove
• Product Code: LZA
• Indications for Use: Nonsterile disposable device for medical purposes, worn on the examiner's hand to prevent contamination between patient and examiner, and tested for use against chemotherapy drugs.
• A table listing specific chemotherapy drugs and their breakthrough times when used with the gloves.

There is no mention of "acceptance criteria" in the context of an algorithm or AI performance, nor is there any study described that would prove an AI device meets acceptance criteria.

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