(239 days)
A 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.
POWDER FREE LATEX EXMAINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM OF 50 µg/dm² OR LESS
This document is a letter from the FDA regarding a 510(k) premarket notification for "Powder-Free Latex Examination Gloves with Protein Content Labeling Claim of 50 ug/dm2 or Less." It is a regulatory approval document and does not contain information about the acceptance criteria or a study proving the device meets those criteria.
Therefore, I cannot provide the requested information. The document focuses on confirming the substantial equivalence of the device to legally marketed predicate devices and outlines the regulatory obligations of the manufacturer. There is no performance data, study design, or expert review mentioned within this 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.