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510(k) Data Aggregation
K Number
K020865Device Name
ONLINE POWDER FREE, LATEX EXAMINATION GLOVES
Manufacturer
Date Cleared
2002-05-08
(51 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
APL PRODUCTS SDN. BHD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
This 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
ONLINE POWDER FREE, LATEX EXAMINATION GLOVES
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K Number
K990879Device Name
PRE POWDERED LATEX EXAMINATION GLOVES
Manufacturer
Date Cleared
1999-05-17
(62 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
APL PRODUCTS SDN. BHD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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K Number
K990901Device Name
POWDER FREE LATEX EXAMINATION GLOVES
Manufacturer
Date Cleared
1999-05-04
(47 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
APL PRODUCTS SDN. BHD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
This glove is a disposable device intended for medical purpose that is worn the examiner's hand to prevent contamination between patient and examiner.
Device Description
POWDER FREE, LATEX EXAMINATION GLOVES - Contains 50 Micrograms or Less of Total Water Extractable Protein Per Gram
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