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Found 4 results
510(k) Data Aggregation
K Number
K092874Device Name
POWDER FREE NITRILE (DARK BLUE) EXAMINATION GLOVES
Manufacturer
Date Cleared
2010-06-22
(277 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
QUALITY GALLANT SDN. BHD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A powder-free, non-sterile patient examination glove is a disposable device made of synthetic material that is intended for medical purposes to be worn on the examiner's hand or finger(s) to prevent contamination between patient and examiner.
Device Description
POWDER FREE NITRILE (DARK BLUE) EXAMINATION GLOVES.
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K Number
K081592Device Name
POWDER FREE NITRILE (BLUE AND WHITE) EXAMINATION GLOVES
Manufacturer
Date Cleared
2008-12-03
(180 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
QUALITY GALLANT SDN. BHD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A powder-free patient examination glove is a disposable device made of synthetic material that is intended for medical purposes to be worn on the examiner's hand or finger(s) to prevent contamination between patient and examiner.
Device Description
POWDER FREE NITRILE (BLUE AND WHITE) EXAMINATION GLOVES
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K Number
K071322Device Name
POWDER FREE LATEX EXAMINATION GLOVES
Manufacturer
Date Cleared
2007-07-13
(64 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
QUALITY GALLANT SDN. BHD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A powder-free patient examination glove is a disposable device made of natural rubber latex or synthetic material that may bear a trace amount of glove powder and is intended to be worn on the hand or finger(s) for medical purposes to provide a barrier against potentially infectious materials and other contaminants.
Device Description
POWDER FREE LATEX EXMAINATION GLOVES
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K Number
K071323Device Name
POWDERED LATEX EXAMINATION GLOVES
Manufacturer
Date Cleared
2007-06-22
(43 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
QUALITY GALLANT SDN. BHD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
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 purpos patient and examiner.
Device Description
POWDERED LATEX EXMAINATION GLOVES
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