Search Results
Found 6 results
510(k) Data Aggregation
K Number
K024083Device Name
GREEN POWDER FREE NITRILE MEDICAL EXAMINATION GLOVES WITH PEPPERMINT FLAVOR
Manufacturer
SUPERMAX GLOVE MANUFACTURING SDN BHD
Date Cleared
2003-01-10
(30 days)
Product Code
LZA
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
SUPERMAX GLOVE MANUFACTURING SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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
Green Powder Free Nitrile Medical Examination Gloves with Peppermint Flavor.
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K Number
K014230Device Name
STERILE POWDER FREE LATEX SURGEON GLOVES WITH PROTEIN LABELING CLAIM (50 MICROGRAM OR LESS)
Manufacturer
SUPERMAX GLOVE MANUFACTURING SDN BHD
Date Cleared
2002-03-13
(77 days)
Product Code
KGO
Regulation Number
878.4460Why did this record match?
Applicant Name (Manufacturer) :
SUPERMAX GLOVE MANUFACTURING SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A surgeon's-glove is a device made of natural or synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. (21CFR 878.4460)
Device Description
Sterile Powder Free Latex Surgeon Gloves with Protein Content Labeling Claim (50 micrograms or less)
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K Number
K013953Device Name
AURELIA CHLORINATED POWDER FREE LATEX MEDICAL EXAMINATION GLOVES WITH ALOE VERA AND GINSENG WITH PROTEIN LABELING CLAIM
Manufacturer
SUPERMAX GLOVE MANUFACTURING SDN BHD
Date Cleared
2002-02-26
(88 days)
Product Code
LYY
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
SUPERMAX GLOVE MANUFACTURING SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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
Aurelia Chlorinated Powder Free Latex Medical Examination Gloves with Aloe Vera and Ginseng with Protein label claim (50 microgram or less)
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K Number
K013589Device Name
CHLORINATED POWDER FREE LATEX MEDICAL EXAMINATION GLOVES WITH ALOE VERA
Manufacturer
SUPERMAX GLOVE MANUFACTURING SDN BHD
Date Cleared
2002-01-08
(70 days)
Product Code
LYY
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
SUPERMAX GLOVE MANUFACTURING SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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 Latex Medical Examination Gloves with Aloe Vera and Protein Content labeling Claim (50 micrograms or less)
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K Number
K010198Device Name
STERILE POWDERED LATEX SURGEON GLOVES
Manufacturer
SUPERMAX GLOVE MANUFACTURING SDN BHD
Date Cleared
2001-02-23
(32 days)
Product Code
KGO
Regulation Number
878.4460Why did this record match?
Applicant Name (Manufacturer) :
SUPERMAX GLOVE MANUFACTURING SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K000644Device Name
SUPERGLOVES STERILE POWDERED LATEX EXAMINATION GLOVES
Manufacturer
SUPERMAX GLOVE MANUFACTURING SDN BHD
Date Cleared
2000-03-17
(21 days)
Product Code
LYY
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
SUPERMAX GLOVE MANUFACTURING SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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