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510(k) Data Aggregation
K Number
K031335Device Name
POWDER FREE LATEX EXAM GLOVES
Manufacturer
Date Cleared
2003-10-16
(171 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
TAN SIN LIAN INDUSTRIES SDN. BHD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Powder Free Patient Examination Gloves is a disposable device made of natural rubber latex that may bear a trace amount of glove powder and is intended to be worn on the hand for medical purposes to provide a barrier against potential infectious materials and other contaminants.
Device Description
Powder Free Latex Examination Gloves
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K Number
K992557Device Name
QUALATEX POWDERED LATEX EXAMINATION GLOVES
Manufacturer
Date Cleared
1999-09-14
(46 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
TAN SIN LIAN INDUSTRIES SDN. BHD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A patient examination gloves is a disposable device intended for medical purposes that is worn on the examiner hands or fingers to prevent contamination betwen patient and examiner.
Device Description
Powdered patient latex examination gloves
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