(205 days)
A patient examination glove is disposable glove intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Not Found
This document does not contain information about the acceptance criteria or a study proving that a device meets acceptance criteria.
The provided text is an FDA 510(k) clearance letter for a "Latex Examination Powder Free Glove, Aloe Vera" (K193150). It states that the device is substantially equivalent to legally marketed predicate devices.
This type of FDA clearance relies on demonstrating substantial equivalence to a predicate device, rather than performing specific clinical studies to meet pre-defined performance acceptance criteria as would typically be required for a novel device or AI-powered medical device.
Therefore, I cannot provide the requested information, which would typically be found in a performance study report or a different section of a submission for a device that requires such evaluation.
§ 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.