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510(k) Data Aggregation
K Number
K051987Device Name
FLEXISKIN POLYMER COATED LATEX EXAMINATION GLOVES, POWDER FREE, NON-STERILE
Manufacturer
Date Cleared
2005-10-06
(76 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
PT. MANDIRI INTI BUANA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Polymer Coated Latex Examination Glove, Powder Free, Non Sterile is a disposable device and made of Natural Rubber Latex Coated with Polymer Intended for Medical purpose that is worn on the Examiner's hand or finger to prevent contamination between patient and examiner
Device Description
The Polymer Coated Latex Examination Gloves, Powder Free, Non Sterile meets all the requirements of ASTM standard D 3578-01 a22 and FDA 1000 ml Water Leak Test.
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K Number
K042239Device Name
FLEXISKIN POWDER FREE NITRILE EXAMINATION GLOVES, NON STERILE
Manufacturer
Date Cleared
2004-12-16
(120 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
PT. MANDIRI INTI BUANA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
POWDER TREE NITRILE EXAMINATION GLOVES, BLUE NON STERILE is a disposable device and make of Synthetic Is a Gropodosatibits rubber like Characteristics Intended For Medical Purpose that is worn on the Incended roz finger to prevent contamination between patient and examiner -
Device Description
The Powder Free Nitrile Examination Gloves, Blue, Non Sterile meets all the requirements of ASTM standard D 6319-00a53 and FDA 1000 ml Water Leak Test.
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K Number
K031754Device Name
FLEXISKIN POWDER FREE LATEX EXAMINATION GLOVES, NON STERILE
Manufacturer
Date Cleared
2003-06-30
(91 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
PT. MANDIRI INTI BUANA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Powder Free Latex Examination Gloves, Non-Sterile (Contains 50 micrograms or less of Water Extractable Protein per gram) is a disposable device and made of Natural Rubber Latex intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Device Description
The Powder Free Latex Examination Gloves, Non Sterile (Contains 50 micrograms or less of Total Water Extractable Protein per gram) meets all the requirements of ASTM standard D 3578 - 01a 22 and FDA 1000 ml Water Leak Test.
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K Number
K031020Device Name
FLEXISKIN LATEX EXAMINATION GLOVES, POWDERED, NON STERILE
Manufacturer
Date Cleared
2003-05-21
(51 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
PT. MANDIRI INTI BUANA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Latex Examination Gloves, Powdered, Non-Sterile is a disposable device and made of Natural Rubber Latex intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Device Description
The Latex Examination Gloves, Powdered, Non Sterile meets all the reguirements of ASTM standard D 3578 - 01a22 and FDA 1000 ml Water Leak Tost.
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