(112 days)
A medical examination glove is worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.
Chlorinated Powder Free Nitrile Medical Examination Gloves with Aloe Vera
The provided document is a 510(k) premarket notification letter from the FDA regarding "Aurella Chlorinated Powder Free Nitrile Medical Examination Gloves with Aloe Vera." This document is a regulatory approval for a medical device (gloves) and does not contain information about software or AI-powered devices, nor does it detail a study with acceptance criteria and performance metrics in the way a clinical validation study for such a device would.
Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth for an AI-powered device from this document. The document primarily focuses on FDA's determination of substantial equivalence for a physical medical product (gloves) to legally marketed predicate devices.
§ 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.