(92 days)
The Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue) is a non - sterile disposable device intended for medical purpose that is worn on the examination between patient and examiner
Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue)
I am sorry, but this document does not contain the information requested. The document is an FDA 510(k) clearance letter for a Nitrile Powder Free Examination Glove, which is a medical device. It details the regulatory approval process and requirements but does not include information about acceptance criteria, study data, ground truth establishment, or sample sizes related to the performance of an AI-powered device.
§ 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.