(150 days)
A medical gloves is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and patient.
Powder Free Latex Patient Examination Gloves
This document, a 510(k) premarket notification from the FDA, deals with the regulatory clearance of "Powder Free Latex Patient Examination Gloves". It focuses on establishing substantial equivalence to a legally marketed predicate device, rather than presenting a study demonstrating the device's performance against specific acceptance criteria.
Therefore, the requested information regarding acceptance criteria and a study proving the device meets these criteria cannot be extracted from the provided text. The document confirms the device's clearance for marketing, but does not detail performance studies.
§ 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.