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Found 4 results
510(k) Data Aggregation
K Number
K063776Device Name
ABLE GLOVE LATEX POWDERED EXAMINATION GLOVES
Manufacturer
Date Cleared
2007-03-02
(71 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
BRIGHT ELEMENT SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A patient examination latex Powdered 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 POWDERED EXAMINATION GLOVES
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K Number
K063777Device Name
ABLE GLOVE NITRILE BLUE POWDER FREE EXAMINATION GLOVE
Manufacturer
Date Cleared
2007-02-23
(63 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
BRIGHT ELEMENT 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
K061074Device Name
ABLE GLOVE, NITRILE BLUE POWDERED EXAMINATION GLOVES
Manufacturer
Date Cleared
2006-05-24
(37 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
BRIGHT ELEMENT 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
Nitrile Blue Powdered Examination Glove
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K Number
K061078Device Name
BRIGHT ELEMENT SND BHD LATEX POWDER FREE EXAMINATION GLOVES
Manufacturer
Date Cleared
2006-05-19
(32 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
BRIGHT ELEMENT SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A patient examination Latex 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
Latex Powder Free Examination Glove
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