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510(k) Data Aggregation
K Number
K982218Device Name
NITRILE POWDER-FREE UNISEAL GLOVESManufacturer
Date Cleared
1998-11-30
(159 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
This glove is disposable and intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
Device Description
UNISEAL POWDER-FREE NITRILE EXAMINATION GLOVES
AI/ML Overview
I'm sorry, but this document contains a letter from the FDA regarding the substantial equivalence of Uniseal Nitrile Powder-Free Examination Gloves to a predicate device. It does not contain information about acceptance criteria and a study proving a device meets those criteria, as requested in your prompt. The document is a regulatory notification, not a performance study report.
Therefore, I cannot extract the requested information from this document.
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