(54 days)
This medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient.
Powder-Free Latex Examination Gloves
I am sorry, but the provided text is a letter from the FDA regarding a 510(k) submission for "Powder-Free Latex Examination Glove with Trade Name: Protein Labeling Claim". This document is a regulatory approval letter and does not contain information about the acceptance criteria, study details, or performance metrics of a device in the context of an AI or medical imaging device, which your questions seem to imply.
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.