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A powder-free patient examination glove is a disposable device made of natural rubber latex material that is intended for medical purposes to be worn on the examiner's hand or finger(s) to prevent contamination between patient and examiner.

POWDER FREE LATEX (PINK) EXAMINATION GLOVES. A powder-free patient examination glove is a disposable device made of natural rubber latex material.

The provided text is a letter from the FDA regarding a 510(k) premarket notification for "Powder Free Latex (Pink) Examination Gloves." It confirms the device is substantially equivalent to legally marketed predicate devices and outlines regulatory requirements.

This document does not contain information about acceptance criteria or a study that proves the device meets those criteria for an AI/ML medical device.

The document pertains to the regulatory clearance of a physical medical device (examination gloves), not a software or AI-based device. Therefore, it does not include details such as:

• A table of acceptance criteria and reported device performance (for AI/ML metrics like sensitivity, specificity, AUC).
• Sample sizes for test sets, data provenance, or numbers/qualifications of experts for ground truth.
• Adjudication methods.
• MRMC comparative effectiveness studies or standalone algorithm performance.
• Types of ground truth for AI/ML models.
• Sample sizes for training sets or how their ground truth was established.

The "Indications for Use" section simply describes the intended use of the physical gloves to prevent contamination.

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