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510(k) Data Aggregation
K Number
K030386Device Name
POWDER FREE SYNTHETIC NITRILE NEOPRENE EXAMINATION GLOVES, SIZES SMALL,MEDIUM, LARGE, AND X-LARGE
Manufacturer
Date Cleared
2003-03-28
(51 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
SHAMROCK MANUFACTURING COMPANY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Powder free Synthetic Nitrile Neoprene Examination Gloves is a disposable device intended for medical purpose that is worn on examiner's hand to prevent contamination between patient and examiner.
Device Description
Powder free Synthetic Nitrile Neoprene Examination Gloves
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K Number
K012786Device Name
POWDERFREE NITRILE NEOPRENE EXAMINATION GLOVES (PULPLE)
Manufacturer
Date Cleared
2001-10-01
(42 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
SHAMROCK MANUFACTURING COMPANY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Powderfree Nitrile Neoprene Examination Glove is a disposable device intended for medical purpose that is worn on examiner's hand to prevent contamination between patient and examiner.
Device Description
Powder free Nitrile Neoprene Examination Gloves is a disposable device intended for medical purpose that is worn on examiner's hand to prevent contamination between patient and examiner.
Ask a Question
Ask a specific question about this device
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