(64 days)
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.
Not Found
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.
§ 880.6250 Non-powdered patient examination glove.
(a)
Identification. A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.