(48 days)
A medical glove is worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.
Not Found
The provided text is a letter from the FDA regarding a 510(k) clearance for "Dash, 'Vital Gard' Powderfree Blue Nitrile Examination Gloves." This document does not contain the information requested about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth for an AI/ML medical device.
The document is a clearance letter for a medical glove, which is a physical product, not a software or AI/ML device. Therefore, the concepts outlined in the request (such as acceptance criteria for AI performance, training/test sets, ground truth establishment by experts, MRMC studies) are not applicable to the content of this FDA letter.
§ 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.