(69 days)
Medline Powder-Free Blue Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs) 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.
Medline Powder-Free Blue Nitrile Examination Gloves (Tested for use with Chemotheraphy Drugs)
This document is a 510(k) clearance letter from the FDA for Medline Powder-Free Blue Nitrile Examination Gloves. It primarily addresses regulatory approval and does not contain information about studies proving the device meets acceptance criteria related to its performance beyond its intended medical purpose. The letter confirms the device is substantially equivalent to legally marketed predicate devices, but it does not include performance data, study designs, or details on ground truth establishment that would typically be found in a clinical study report or technical documentation for device performance.
Therefore, I cannot extract the requested information regarding acceptance criteria and performance studies from the provided text.
§ 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.