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Found 4 results
510(k) Data Aggregation
K Number
K071207Device Name
MASTER GUARD NITRILE BLUE POWDERED EXAMINATION GLOVES
Manufacturer
Date Cleared
2007-08-07
(98 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
HIGH MOMENTUM SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A patient examination Nitrile Blue Powdered Glove is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
Device Description
Master Guard Disposable Nitrile Powdered Blue Examination Gloves
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K Number
K071208Device Name
MASTER GUARD NITRILE BLUE POWDER FREE EXAMINATION GLOVES
Manufacturer
Date Cleared
2007-07-30
(90 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
HIGH MOMENTUM SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A patient examination Nitrile Blue Powder Free Glove is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
Device Description
Nitrile Blue Powder Free Examination Glove
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K Number
K071209Device Name
MASTER GUARD LATEX POWDER FREE EXAMINATION GLOVES
Manufacturer
Date Cleared
2007-07-25
(85 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
HIGH MOMENTUM SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A patient examination Latex Powder Free Gloves is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
Device Description
Latex Powder Free Examination Gloves
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K Number
K060858Device Name
LATEX POWDERED EXAMINATION GLOVE
Manufacturer
Date Cleared
2006-06-08
(71 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
HIGH MOMENTUM SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A patient examination Latex Powdered Glove is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
Device Description
Latex Powdered Examination Glove
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