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510(k) Data Aggregation
K Number
K983828Device Name
NITRIKLEEN- NITRILE EXAMINATION GLOVE POWDER FREE
Manufacturer
Date Cleared
1999-01-21
(83 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
SINETIMED 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 on the hand of examiner to prevent contamination between patient and examiner.
Device Description
NITRILE PATIENT EXAMINATION GLOVES, POWDER FREE
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K Number
K983827Device Name
MAXIKLEEN-LATEX EXAMINATION GLOVE POWDER FREE
Manufacturer
Date Cleared
1999-01-14
(76 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
SINETIMED 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 on the hand of examiner to prevent contamination between patient and examiner.
Device Description
LATEX PATIENT EXAMINATION GLOVES, POWDER FREE
Ask a Question
Ask a specific question about this device
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