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Found 7 results
510(k) Data Aggregation
K Number
K113393Device Name
POWDER FREE BLACK NITRILE EXAMINATION GLOVES
Manufacturer
Date Cleared
2012-09-11
(299 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
TG MEDICAL SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A Powder-free pateint examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Device Description
Powder Free Black Nitrile Examination Gloves
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K Number
K993562Device Name
POWDER FREE LATEX STERILE SURGICAL GLOVES
Manufacturer
Date Cleared
1999-12-29
(69 days)
Product Code
Regulation Number
878.4460Why did this record match?
Applicant Name (Manufacturer) :
TG MEDICAL SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The surgical glove is a device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination between the patient and the surgeon.
Device Description
LATEX SURGICAL POWDERFREE GLOVES
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K Number
K992841Device Name
TG MEDICAL POWDERED NITRILE BLUE EXAMINATION GLOVES
Manufacturer
Date Cleared
1999-10-29
(66 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
TG MEDICAL SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
POWDERED NITRILE BLUE EXAMINATION GLOVES ARE WORN ON THE HANDS OF HEALTH CARE AND SIMILAR PERSONNEL TO PREVENT CONTAMINATION BETWEEN HEALTH CARE PERSONNEL AND THE PATIENT.
Device Description
POWDERED NITRILE BLUE EXAMINATION GLOVES
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K Number
K992360Device Name
TG MEDICAL POWDERED NITRILE EXAMINATION GLOVES
Manufacturer
Date Cleared
1999-10-12
(89 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
TG MEDICAL SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
POWDERED NITRILE EXAMINATION GLOVES ARE WORN ON THE HANDS 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
K992219Device Name
POWDERED LATEX STERILE SURGICAL GLOVES
Manufacturer
Date Cleared
1999-07-30
(29 days)
Product Code
Regulation Number
878.4460Why did this record match?
Applicant Name (Manufacturer) :
TG MEDICAL SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The surgical glove is a device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination between the patient and the surgeon.
Device Description
LATEX SURGICAL GLOVE, POWDERED AND STERILE
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K Number
K990668Device Name
POWDER FREE BLUE NITRILE GLOVE
Manufacturer
Date Cleared
1999-06-03
(93 days)
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
TG MEDICAL SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The glove is disposable and intended for Medical purpose that is worn on the examiner's hand to prevent contamination between the patient and the examiner.
Device Description
POWDER FREE BLUE NITRILE GLOVE
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K Number
K982872Device Name
TG MEDICAL POWDER-FREE LATEX EXAMINATION GLOVE PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS)
Manufacturer
Date Cleared
1998-10-15
(62 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
TG MEDICAL SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Latex examination powderfree gloves are worn on the hands of health care and bales examination poracite contamination between health care personnel and the patient.
Device Description
LATEX EXAMINATION POWDERFREE GLOVES With Protein Labeling Claims (50mg or less)
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