(69 days)
The patient examination gloves is a disposable device intended for medical and dental purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Powder Free Latex Examination Gloves with Protein Content Labeling Claim of 50 micrograms or less.
This document set is a 510(k) premarket notification letter from the FDA, approving a medical device. It does not contain information about the acceptance criteria or a study proving that the device meets those criteria. The provided text is regulatory correspondence, not a technical study report.
Therefore, I cannot extract the requested information as it is not present in the given 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.