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510(k) Data Aggregation
K Number
K133949Device Name
POWDER FREE NITRILE PATIENT EXAMINATION GLOVE,BLUE AND ORANGE COLORED,NON-STERILE TESTED FOR USE WITH CHEMOTHERAPY DRUGS
Manufacturer
Date Cleared
2014-04-08
(106 days)
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
TOP CALIBRE SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. This glove has been tested for use with specific chemotherapy drugs listed below.
Device Description
Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Powder Free Nitrile Patient Examination Glove, Orange Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs meet all of the requirements of ASTM D6319-10. The gloves are ambidextrous single-use disposable devices that come in five sizes (XS, S, M, L, XL) in blue or orange color.
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K Number
K123819Device Name
MULTIPLE NAME
Manufacturer
Date Cleared
2013-03-05
(83 days)
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
TOP CALIBRE SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. This glove has been tested for use with specific chemotherapy drugs listed below.
Device Description
Powder Free Latex Patient Examination Glove, Blue, Tested for Use with Chemotherapy Drugs, with Protein Content Labeling Claim (Contains 50 Micrograms per dm2 of glove or Less of Water Extractable Protein) meets all the current specification for ASTM D3578-05 (2010). The gloves are non-sterile, ambidextrous and single-use disposable devices that come in five sizes (XS, S, M, L, XL).
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K Number
K120692Device Name
LATEX EXAMINATION GLOVES (POWDER FREE)
Manufacturer
Date Cleared
2012-05-14
(68 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
TOP CALIBRE SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Device Description
Powder Free Latex Patient Examination Glove, with Protein Content Labeling Claim, Chlorinated (Contains 50 Micrograms per dm2 of glove or Less of Water Extractable Protein) meets all the current specification for ASTM D3578-05 (2010).
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K Number
K120693Device Name
LATEX EXAMINATION GLOVES (POWDERED)
Manufacturer
Date Cleared
2012-05-08
(62 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
TOP CALIBRE SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Device Description
Powdered Latex Patient Examination Glove with Protein Content Labeling Claim (Contains 200 Micrograms per dm2 of glove or Less of Water Extractable Protein) meets all the current specification for ASTM D3578-05 (2010).
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K Number
K112612Device Name
POWDER FREE LATEX PATIENT EXAMINATION GLOVE, WITH PROTEIN CONTENT LABELING CLAIM
Manufacturer
Date Cleared
2012-01-18
(133 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
TOP CALIBRE SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Device Description
Powder Free Latex Patient Examination Glove with Protein Content Labeling Claim (Contains 50 Micrograms per dm2 of glove or Less of Water Extractable Protein) meets all the current specification for ASTM D3578-05 (2010).
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