Search Results

A Vinyl examination glove , Powder Free, Clear( Non-Colored ) 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.

Vinyl Examination Glove, Powder Free, Non-Colored

I am sorry, but the provided text is a 510(k) premarket notification acceptance letter from the FDA regarding a "Vinyl Examination Glove, Powder Free, Non-Colored." This document does not contain information about acceptance criteria, study details, performance data, sample sizes, expert qualifications, or ground truth establishment relevant to an AI/ML medical device.

The request asks for specific details related to the evaluation of an AI-powered medical device, such as:

• Acceptance criteria and reported device performance.
• Sample size and data provenance for test sets.
• Number and qualifications of experts for ground truth.
• Adjudication methods.
• MRMC study results, if applicable.
• Standalone performance.
• Type of ground truth used.
• Training set sample size and ground truth establishment.

None of this information is present in the provided FDA letter for a VINYL EXAMINATION GLOVE. This device is a Class I medical device (patient examination glove) and not an AI/ML-based diagnostic or analytical tool. Evaluation for such devices primarily focuses on material safety, barrier integrity, and physical properties, not on algorithmic performance or expert consensus for interpretation.

Ask a specific question about this device

The Stretch Vinyl examination glove, Powder Free, Yellow/White 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.

Powder-Free, Stretch Vinyl Examination Gloves, Yellow/White

This document is a 510(k) clearance letter from the FDA for medical examination gloves. It does not contain information about the acceptance criteria or a study proving that a device meets those criteria, as such information would typically be found in the 510(k) submission itself or in a separate performance study report, not in the clearance letter.

Therefore, I cannot provide the requested details based on the provided text.

Ask a specific question about this device