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510(k) Data Aggregation
K Number
K033530Device Name
ASIA PACIFIC LATEX SDN. BHD. POWDER FREE LATEX EXAMINATION GLOVES
Manufacturer
Date Cleared
2004-01-28
(79 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
ASIA PACIFIC LATEX SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Powder Free Latex Examination Gloves is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Device Description
Powder Free Latex Examination Gloves
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K Number
K033532Device Name
ASIA PACIFIC LATEX SDN. BHD. POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES
Manufacturer
Date Cleared
2004-01-28
(79 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
ASIA PACIFIC LATEX SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient & examiner.
Device Description
Not Found
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K Number
K982274Device Name
NITRILE PATIENT EXAMINATION GLOVE POWDER FREE
Manufacturer
Date Cleared
1998-08-11
(43 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
ASIA PACIFIC LATEX 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
NITRILE PATIENT EXAMINATION GLOVES, POWDER FREE
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