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Found 7 results
510(k) Data Aggregation
K Number
K122131Device Name
POWDER FREE NITRILE EXAMINATION GLOVE-BLUE (CHEMOTHERAPY)
Manufacturer
Date Cleared
2012-10-17
(91 days)
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
MATANG MFG. SDN. BHD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A Powder Free Nitrile Examination Glove - Blue (Chemotherapy) is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between the patient and examiner. In addition, these Chemotherapy gloves were tested for use with the following drug concentrations per ASTM D 6978-05
Device Description
Powder Free Nitrile Examination Glove - Blue (Chemotherapy)
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K Number
K121368Device Name
NITRILE EXAMINATION GLOVE, POWDER FREE (BLUE, BLACK OR WHITE)
Manufacturer
Date Cleared
2012-08-10
(95 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
MATANG MFG. SDN. BHD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A Colored Nitrile Examination Glove - Powder Free (Blue, Black and White) is a disposable device made of Nitrile latex that may bear a trace amount of glove powder and is intended to be worn on the hands or finger(s) for medical purposes to provide a barrier against potentially infectious materials and other contaminants. A colors blue, black and white will be added to the nitrile examination glove in the production process to produce the colored gloves.
Device Description
A Colored Nitrile Examination Glove - Powder Free (Blue, Black and White) is a disposable device made of Nitrile latex that may bear a trace amount of glove powder and is intended to be worn on the hands or finger(s) for medical purposes to provide a barrier against potentially infectious materials and other contaminants. A colors blue, black and white will be added to the nitrile examination glove in the production process to produce the colored gloves.
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K Number
K072614Device Name
MATANG BLACK, POWDER FREE AND POLYMER COATED LATEX EXAMINATION GLOVE
Manufacturer
Date Cleared
2008-04-15
(211 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
MATANG MFG. SDN. BHD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A black, powder free and polymer coated latex examination glove is a disposable device made of natural latex that may bear a trace amount of glove powder and is intended to be worn on the hands or finger(s) for medical purposes to provide a barrier against potentially infectious materials and other contaminants. A black pigment is added to the latex in the production process to produce the black colored glove.
Device Description
Black, Powder Free and Polymer Coated Latex Examination Glove with a Protein Claim of Less Than 50 µg/gm Glove
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K Number
K032549Device Name
MATANG POWDER-FREE POLYCHLOROPRENE PATIENT EXAMINATION GLOVES
Manufacturer
Date Cleared
2003-09-08
(21 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
MATANG MFG. SDN. BHD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient.
Device Description
Powder-Free Polychloroprene Patient Examination Glove
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K Number
K012558Device Name
POWDER FREE LATEX PATIENT EXAMINATION GLOVES WITH ALOE VERA AND PROTEIN CONTENT LABELING CLAIM OF 50 MICROGRAMS OR LESS
Manufacturer
Date Cleared
2001-09-17
(40 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
MATANG MFG. SDN. BHD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient.
Device Description
Matang Powder-Free Latex Patient Examination Gloves with Matang - San Protein Content Labeling Claim of 50 Micrograms or less of total water extractable protein per gram.
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K Number
K000985Device Name
MATANG POWDERED LATEX PATIENT EXAMINATION GLOVE WITH PROTEIN LABELING CLAIM (50 MICROGRAM OR LESS
Manufacturer
Date Cleared
2000-04-24
(28 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
MATANG MFG. SDN. BHD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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K Number
K982877Device Name
MATANG POWDER-FREE LOW PROTEIN LATEX PATIENT EXAMINATION GLOVE
Manufacturer
Date Cleared
1998-11-30
(108 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
MATANG MFG. SDN. BHD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient.
Device Description
Matang Powder-Free Latex Patient Examination Glove, with Protein Labeling Claim (50 Micrograms or Less)
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