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510(k) Data Aggregation
K Number
K971356Device Name
POWDER FREE SYNTHETIC EXAMINATION GLOVESManufacturer
Date Cleared
1997-09-05
(147 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 purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Device Description
Powder Free Blue Nitrile Examination Gloves
AI/ML Overview
The provided text is a letter from the FDA regarding the clearance of "Powder Free Nitrile Examination Gloves." It does not contain information about the acceptance criteria and study that proves the device meets the acceptance criteria. The letter primarily addresses the substantial equivalence determination for regulatory purposes. Therefore, I cannot extract the requested information from the given text.
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