(71 days)
A medical gloves is worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.
NITRILE EXAMINATION GLOVES, NON-STERILE, POWDER FREE.
The provided document is a 510(k) clearance letter from the FDA for "Arsoft Nitrile Examination Gloves, Non-Sterile Powder-Free." This document does not contain information about acceptance criteria or a study proving that a device meets those criteria, as it relates to an AI/ML-enabled medical device.
The letter is a regulatory approval for a physical medical device (gloves) based on substantial equivalence to a predicate device, not on performance criteria measured through a clinical or technical study in the context of AI/ML.
Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details from this 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.