(400 days)
A medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and patient.
Powder Free Latex Patient Examination Gloves
The provided text describes a 510(k) premarket notification for "Powder Free Latex Patient Examination Gloves". This document is a regulatory approval letter from the FDA, not a study evaluating the performance or acceptance criteria of an AI or medical device with specific performance metrics.
Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment because the document does not contain this type of data. It is a regulatory approval for a physical product (gloves) based on substantial equivalence, not a performance study of a device against specific clinical or technical metrics.
§ 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.