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510(k) Data Aggregation
K Number
K011012Device Name
POWDER FREE NITRILE EXAMINATION GLOVE
Manufacturer
Date Cleared
2001-05-01
(27 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
CONTRACT LATEX DIPPERS SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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K Number
K983568Device Name
OSTAR D'PRO LATEX POWDERED EXAMINATION GLOVES, PROTEIN CLAIM OF 100 MCGM OR/LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER
Manufacturer
Date Cleared
1998-12-21
(69 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
CONTRACT LATEX DIPPERS SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Ostar D'Pro glove is a disposable patient examination The Ostal D ITO glove the hand of healthcare and similar personnel to prevent contamination between patient and examiner.
Device Description
Ostar D'Pro Latex Powdered Examination Gloves, Protein Claim of 100 mcgm or less of Total Water Extractable Protein Per Gram
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K Number
K955947Device Name
OSTAR EXAMINATION GLOVES
Manufacturer
Date Cleared
1996-06-10
(195 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
CONTRACT LATEX DIPPERS SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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K Number
K954063Device Name
GLOVE SEAL & SET-RITE
Manufacturer
Date Cleared
1996-06-05
(281 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
CONTRACT LATEX DIPPERS SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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