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510(k) Data Aggregation
K Number
K033533Device Name
POWDER FREE LATEX EXAMINATION GLOVES
Manufacturer
Date Cleared
2004-06-24
(227 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
APL INTERNATIONAL INCORPORATED LIMITED
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's hand or fingers to prevent contamination between patient and examiner.
Device Description
Powder Free Latex Examination Gloves Contains 50 microgram or less of total water Extractable Protein per gram
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K Number
K033531Device Name
POWDERED LATEX EXAMINATION GLOVES
Manufacturer
Date Cleared
2004-03-03
(114 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
APL INTERNATIONAL INCORPORATED LIMITED
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's hand or fingers to prevent contamination between patient and examiner.
Device Description
Powdered Latex Examination Gloves Contains 200 microgram or less of total water Extractable Protein per gram
Ask a Question
Ask a specific question about this device
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