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Found 3 results
510(k) Data Aggregation
K Number
K970977Device Name
LATEX EXAMINATION GLOVES, POWDER FREE
Manufacturer
Date Cleared
1997-06-27
(105 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
ARISTA MEDI PRIMA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A patient examination glove is a disposable device intended for medical purpose 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
K964629Device Name
VINYL PATIENT EXAMINATION GLOVES
Manufacturer
Date Cleared
1997-02-10
(83 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
ARISTA MEDI PRIMA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K963742Device Name
LATEX EXAMINATION GLOVES, POWDERED
Manufacturer
Date Cleared
1996-11-20
(64 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
ARISTA MEDI PRIMA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
Ask a Question
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