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Found 7 results
510(k) Data Aggregation
K Number
K013774Device Name
CHLORINATED POWDER FREE NITRILE MEDICAL EXAMINATION GLOVES WITH ALOE VERA
Manufacturer
Date Cleared
2002-03-05
(112 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
SUPERMAX SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A medical examination glove is worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.
Device Description
Chlorinated Powder Free Nitrile Medical Examination Gloves with Aloe Vera
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K Number
K993864Device Name
COLORED AND FLAVORED POWDER FREE LATEX EXAMINATION GLOVES
Manufacturer
Date Cleared
2000-01-20
(66 days)
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
SUPERMAX SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A powder free patient examination glove is a disposable device made of latex material that may bear a trace amount of glove powder and is intended to be worn on the hand or fingers for medical purposes to provide a barrier against potential infectious materials and other contaminants.
Device Description
Not Found
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K Number
K993865Device Name
GREEN PEPPERMINT FLAVORED POWDERED LATEX EXAMINATION GLOVES
Manufacturer
Date Cleared
2000-01-20
(66 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
SUPERMAX SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A powdered patient examination glove is a disposable device made of latex material that may bear a trace amount of glove powder and is intended to be worn on the hand or fingers for medical purposes to provide a barrier against potential infectious materials and other contaminants.
Device Description
GREEN PEPPERMINT FLAVORED POWDERED LATEX EXAMINATION GLOVES
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K Number
K993258Device Name
SUPERGLOVES, POWDER FREE NITRILE EXAMINATION GLOVES
Manufacturer
Date Cleared
1999-10-27
(28 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
SUPERMAX SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A nowder liee patient examination glove is a disposable device made of synthetic material that may bear a tracc annount of glove powder and is intended to be worn on the hand or fingers for medical purposes to provide a barrier against potential infectious materials and other contaminants.
Device Description
POWDER FREE NITRILE EXAMINATION GLOVES
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K Number
K991415Device Name
SUPERGLOVES, POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES
Manufacturer
Date Cleared
1999-05-26
(33 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
SUPERMAX SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A medical examination glove is worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient." [50 Microgram or less Protein labeling Claim]
Device Description
Polymer Coated Powder Free Latex Examination Gloves
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K Number
K980966Device Name
SUPERGLOVES POWDERED NITRILE
Manufacturer
Date Cleared
1998-07-22
(128 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
SUPERMAX SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A medical examination glove is worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.
Device Description
Powdered Nitrile Examination Gloves
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K Number
K980494Device Name
SUPERGLOVES
Manufacturer
Date Cleared
1998-06-09
(120 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
SUPERMAX SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A medical examination glove is worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.
Device Description
Latex powdered patient examination gloves with 70 mcgm or less of total water extractable protein per gram
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