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A single use disposable device intended for medical purposes that is worn on the hands of examiners to prevent contamination between the examiner and the patient.

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The provided text is an FDA 510(k) clearance letter for "Ivory Glove Nitrile Examination Gloves." This document does not contain any information about acceptance criteria or a study proving that a device meets those criteria, as it pertains to AI/ML medical devices.

Instead, it's a regulatory clearance for a physical medical device (examination gloves), indicating that it's substantially equivalent to previously marketed devices. The document outlines:

• The device name: Ivory Glove Nitrile Examination Gloves
• Regulation number and name: 21 CFR 880.6250, Non-Powdered Patient Examination Glove
• Regulatory class: Class I
• Product code: LZA
• Indications for Use: "A single use disposable device intended for medical purposes that is worn on the hands of examiners to prevent contamination between the examiner and the patient."
• Type of Use: Over-The-Counter Use

Therefore, I cannot extract the requested information (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, training set details) because this document is utterly irrelevant to AI/ML device performance and evaluation.

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