(65 days)
Latex examination powderfree gloves are worn on the hands of health care and similar personnel to prevent contamination between health care personnel and the patient.
Not Found
This document is a 510(k) premarket notification from the FDA for medical gloves. It does not contain any information about acceptance criteria or a study that proves a device meets those criteria for software or AI-based medical devices.
The provided text pertains to a traditional medical device (latex examination gloves) and the FDA's substantial equivalence determination for its marketing. Therefore, I cannot extract the requested information regarding acceptance criteria and a study 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.