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Patient Examination Glove is a disposable device which is primarily intended for medical purposes worn on the examiner's hand or finger to prevent contamination between patient and examiner. These gloves are STRICTLY NOT intended for surgical use or as a substitute for surgery puposes.

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I am sorry, but the provided text from the FDA document (K993793) is a 510(k) clearance letter for a "Pre-powdered latex patient examination glove". This document focuses on the regulatory clearance process, stating that the device is substantially equivalent to legally marketed predicate devices, and outlines the general controls and regulations applicable to such devices.

The document does not contain information about:

• Specific acceptance criteria for the device's performance.
• Results of any study proving device performance against acceptance criteria.
• Details about sample sizes, data provenance, expert qualifications, adjudication methods, or ground truth establishment.
• Any multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance studies, as this is a physical medical device (gloves), not an AI/software device.

Therefore, I cannot provide a response with the requested information based on the input document.

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