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510(k) Data Aggregation
K Number
K022702Device Name
POWDERED SYNTHETIC VINYL EXAM GLOVESManufacturer
Date Cleared
2002-09-16
(33 days)
Product Code
Regulation Number
880.6250Type
TraditionalPanel
General HospitalReference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
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.
Device Description
Powdered Synthetic Vinyl Examination Glove
AI/ML Overview
This document only discusses the FDA's decision to allow the marketing of "Powdered Synthetic Vinyl Examination Gloves" and does not contain information about acceptance criteria or a study proving the device meets those criteria. It is a 510(k) premarket notification letter, which indicates substantial equivalence to a predicate device, rather than a clinical study report. Therefore, I cannot extract the requested information.
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