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A patient examination glove that is worn by the healthcare or similar personnel to prevent contamination between the healthcare personnel and the patient

Powder-Free Nitrile Examination Glove, (Purple)

The provided text is an FDA 510(k) clearance letter for Powder-Free Nitrile Examination Gloves. It primarily confirms the device's substantial equivalence to a predicate device and outlines general regulatory obligations.

Therefore, the document does not contain any information regarding:

• Acceptance criteria and reported device performance (in terms of specific metrics like sensitivity, specificity, accuracy, etc.)
• Details of a study proving the device meets acceptance criteria.
• Sample sizes, data provenance, expert qualifications, or adjudication methods for a test set.
• Multi Reader Multi Case (MRMC) comparative effectiveness studies.
• Standalone algorithm performance.
• Types of ground truth used.
• Sample size or ground truth establishment for a training set.

The 510(k) process for devices like examination gloves typically relies on demonstrating substantial equivalence to a legally marketed predicate device, often through conformance to recognized standards (e.g., ASTM standards for glove integrity) and bench testing, rather than complex clinical studies with AI components, ground truth, or expert review panels.

In summary, none of the requested information about acceptance criteria or specific study details for proving performance is available in the provided text. The document focuses on regulatory clearance based on substantial equivalence.

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