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510(k) Data Aggregation
K Number
K092160Device Name
POWDERFREE NITRILE (DARK BLUE) EXAMINATION GLOVES
Manufacturer
Date Cleared
2009-11-27
(134 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
COMFORT RUBBER GLOVES IND. 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 hands or fingers to prevent contamination between patient and examiner.
Device Description
POWDER FREE NITRILE (DARK BLUE ) EXAMINATION GLOVES
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K Number
K083624Device Name
POWDER FREE NITRILE (BLUE AND WHITE) EXAMINATION GLOVES
Manufacturer
Date Cleared
2009-02-10
(64 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
COMFORT RUBBER GLOVES IND. 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 hands or fingers to prevent contamination between patient and examiner.
Device Description
POWDER FREE NITRILE (BLUE AND WHITE) EXAMINATION GLOVES
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Ask a specific question about this device
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