(66 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, POWDERED, GREEN COLOR.
The provided text is a 510(k) clearance letter from the FDA for Nitrile Examination Gloves. It does not contain any information about the acceptance criteria or a study proving device performance in the context of an AI/ML medical device.
Therefore, I cannot fulfill your request for this specific input. The document is a regulatory approval for a physical medical product (gloves), not an AI-powered diagnostic or predictive tool.
§ 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.