(22 days)
A Patient Examination Glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Safety Powderfree Blue Latex Examination Gloves (Polymer Coated)
The provided text is a 510(k) clearance letter from the FDA for "Safety Powderfree Blue Latex Examination Gloves (Polymer Coated)". This document is a regulatory approval for a medical device and does not contain any information regarding acceptance criteria, study details, or performance metrics that would be typically found in a study report.
Therefore, I cannot extract the requested information. The document focuses on confirming the substantial equivalence of the device to a predicate device and outlining the regulatory obligations of the manufacturer.
§ 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.