Search Results

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

Powder-Free Green Polychloroprene Examination Gloves, Powder-Free Blue Polychloroprene Examination Gloves, Powder-Free Brown Polychloroprene Examination Gloves

This document is a 510(k) premarket notification from the FDA regarding "Powder-Free Green Polychloroprene Examination Gloves," "Powder-Free Blue Polychloroprene Examination Gloves," and "Powder-Free Brown Polychloroprene Examination Gloves." It is a regulatory approval letter, not a study describing the acceptance criteria and performance of a device, especially not an AI/ML-based medical device.

Therefore, I cannot provide the requested information because the document does not contain details about:

• A table of acceptance criteria and reported device performance (in the context of AI/ML or clinical efficacy)
• Sample sizes for test sets or data provenance
• Number of experts or their qualifications for establishing ground truth
• Adjudication methods
• Multi-reader multi-case (MRMC) studies or effect sizes
• Standalone algorithm performance
• Types of ground truth used
• Sample size for training sets
• How ground truth for training sets was established

This document is solely an FDA clearance letter for a medical device (examination gloves), confirming its substantial equivalence to previously marketed devices based on its intended use as a barrier to prevent contamination. It does not describe a performance study for complex diagnostic or AI-driven devices.

Ask a specific question about this device