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510(k) Data Aggregation
K Number
K112976Manufacturer
Date Cleared
2012-02-02
(119 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
Device Description
AI/ML Overview
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K Number
K050214Manufacturer
Date Cleared
2005-03-16
(44 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
The nitrile examination gloves is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Device Description
Nitrile Powder Free Examination Gloves
AI/ML Overview
This document is a 510(k) clearance letter from the FDA for Nitrile Powder Free Examination Gloves. It primarily addresses regulatory approval and does not contain information on acceptance criteria, device performance studies, or ground truth establishment. Therefore, I cannot extract the requested information from this document.
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