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Found 6 results
510(k) Data Aggregation
K Number
K111300Device Name
SENSTOUCH NITRILE EXAMINATION GLOVES, POWDER FREE, NON STERILE (GREEN, ORANGE, VIOLET AND WHITE)
Manufacturer
Date Cleared
2011-08-12
(95 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
PT. MAHAKARYA INTI BUANA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Green, Orange, Violet and White Nitrile examination gloves, Powder Free, Non - Sterile are disposable device and made of Synthetic Polymer that exhibits rubber like characteristics intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Device Description
Powder Free Green, Orange, Violet and White Nitrile Examination Gloves, Non Sterile is a disposable device intended for medical purposes that is worn on the examiner's to prevent contamination between patient and examiner.
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K Number
K062313Device Name
SENSTOUCH HIGH RISK LATEX EXAMINATION GLOVES, POWDER FREE, NON STERILE
Manufacturer
Date Cleared
2006-11-30
(114 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
PT. MAHAKARYA INTI BUANA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
High Risk Latex Examination Gloves, Powder Free Non Sterile is a disposable device and made of natural rubber latex for medical purpose that is worn on the examiner's hand or finger to prevent conta mination between patient and examiner.
Device Description
HIGH RISK LATEX EXAMINATION GLOVES, POWDER FREE NON STERILE is a disposable device and made of natural rubber latex.
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K Number
K061233Device Name
SENSTOUCH POWDER FREE EXAMINATION GLOVES, NON STERILE
Manufacturer
Date Cleared
2006-11-03
(185 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
PT. MAHAKARYA INTI BUANA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Latex Examination Glove, Powder Free Non Sterile is a disposable device and made of Natural Rubber Intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner
Device Description
Latex Examination Glove, Powder Free Non Sterile is a disposable device and made of Natural Rubber
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K Number
K053366Device Name
NITRILE EXAMINATION GLOVES, POWDERED, NON STERILE
Manufacturer
Date Cleared
2006-03-30
(115 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
PT. MAHAKARYA INTI BUANA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Powdered Nitrile Examination Gloves, Non -Sterile is a disposable device and made of Synthetic Polymer that exhibits rubber like characteristics intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner.
Device Description
The Powdered 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
K053657Device Name
POWDER FREE NITRILE EXAMINATION GLOVES, NON-STERILE
Manufacturer
Date Cleared
2006-02-13
(70 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
PT. MAHAKARYA INTI BUANA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Powder Free Nitrile Examination. Gloves, Non -Sterile is a disposable device and made of Synthetic Polymer that exhibits rubber like characteristics intended for medical purposes that is worn on the examiner's hands of 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 Icct.
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K Number
K052273Device Name
POLYMER COATED LATEX EXAMINATION GLOVES, POWDER FREE, NON-STERILE
Manufacturer
Date Cleared
2005-09-30
(39 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
PT. MAHAKARYA INTI BUANA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Olymer Examination Glove , Powder Free Non Sterile is a disposable device and made of Synthetic Polymer that exhibits rubber like characteristics intended for medical purpose that is worn on the examiner's hand or finger or prevent contamination between patient and examiner.
Device Description
The Polymer Examination Gloves, Powder Free, Non Sterile (Contains 50 micrograms or less of Total Water Extractable Protein per gram) meets all the requirements of ASTM standard D 3578-01 a22 and FDA 1000 ml Water Leak Test.
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