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A patient examination glove is a NON STERILE disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner

NITRILE EXAMINATION GLOVES POLYMER COATED (WHITE, BLUE and BLACK COLOR)

The provided document is a 510(k) premarket notification letter from the FDA to Innovative Gloves Company, Limited, concerning Nitrile Examination Gloves. It primarily addresses the regulatory approval process and states that the device is substantially equivalent to legally marketed predicate devices.

This document does NOT contain information about:

• Acceptance criteria table or reported device performance for an AI/ML device.
• Sample sizes, data provenance, or details about test datasets.
• Number or qualifications of experts, or adjudication methods for ground truth establishment.
• Multi-reader multi-case (MRMC) comparative effectiveness studies or effect sizes.
• Standalone algorithm performance studies.
• Type of ground truth used (e.g., pathology, outcomes data).
• Training set sample size or how its ground truth was established.

Therefore, I cannot provide the requested information based on the provided text. The document is about the regulatory approval of medical gloves, not a study validating an AI/ML medical device.

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