(66 days)
POWDERED NITRILE BLUE EXAMINATION GLOVES ARE WORN ON THE HANDS OF HEALTH CARE AND SIMILAR PERSONNEL TO PREVENT CONTAMINATION BETWEEN HEALTH CARE PERSONNEL AND THE PATIENT.
POWDERED NITRILE BLUE EXAMINATION GLOVES
The provided document is an FDA 510(k) clearance letter for Powdered Nitrile Blue Examination Gloves. It primarily addresses the regulatory approval of the device and its indications for use. The document does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, or specific ground truth methodologies for evaluating the gloves.
Therefore, I cannot fulfill the request for information on acceptance criteria and supporting studies based on the provided text. The document confirms that the device is "substantially equivalent" to previously marketed devices, which speaks to its regulatory classification rather than detailed performance metrics from a specific study against defined acceptance criteria.
§ 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.