Search Results
Found 9 results
510(k) Data Aggregation
K Number
K051345Device Name
COLORED POWDER FREE AND POLYMER COATED PATIENT EXAMINATION GLOVE (PINK, BLUE, GREEN AND VIOLET)
Manufacturer
GLOVCO (M) SDN. BHD.
Date Cleared
2005-06-23
(31 days)
Product Code
LYY
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
GLOVCO (M) SDN. BHD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A colored, powder free and polymer opated patient examination glove is a disposable device made of natural rubber latex that may bear a trace amount of glove powder and is intended to be wom on the hands or finger(s) for medical purposes to provide a bantier against potentially mlectious materials and other contaminants. The colors, pink, blue, green and violet are added respectively to the latex in the production process for the intended colored glove.
Device Description
Colored Powder Free And Polymer Ceated Patient Examination Glove (Pink, Blue, Green and Violet) With A Protein Claim Of Less Than 50 pargm Glove.
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K Number
K042898Device Name
PANTHERA N POWDER FREE BLACK NITRILE GLOVES
Manufacturer
GLOVCO (M) SDN. BHD.
Date Cleared
2005-01-18
(90 days)
Product Code
LZA
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
GLOVCO (M) SDN. BHD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A powder-free patient examination glove (nitrile) is a disposable device made of synthetic material (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 ntoal paiminants. The glove is black with a carbon black colorant additive and polymer coated.
Device Description
A powder-free patient examination glove (nitrile) is a disposable device made of synthetic material (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 ntoal paiminants. The glove is black with a carbon black colorant additive and polymer coated.
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K Number
K013828Device Name
GLOVCO EBONY
Manufacturer
GLOVCO (M) SDN. BHD.
Date Cleared
2002-08-13
(267 days)
Product Code
LYY
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
GLOVCO (M) SDN. BHD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A patient examination glove that is worn by the healthcare and similar personnel to prevent contamination between healthcare personnel and the patient.
Device Description
Black Coloured Powder-Free Latex Examination Gloves with Protein Labeling Claim (50 micrograms or less)
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K Number
K021730Device Name
GLOVCO BRAND POWDER-FREE NITRILE EXAMINATION GLOVES (PURPLE)
Manufacturer
GLOVCO (M) SDN. BHD.
Date Cleared
2002-07-05
(42 days)
Product Code
LZA
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
GLOVCO (M) SDN. BHD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A patient examination glove that is worn by the healthcare or similar personnel to prevent contamination between the healthcare personnel and the patient
Device Description
Powder-Free Nitrile Examination Glove, (Purple)
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K Number
K021308Device Name
GLOVCO POWDER-FREE NITRILE EXAMINATION GLOVES
Manufacturer
GLOVCO (M) SDN. BHD.
Date Cleared
2002-05-14
(19 days)
Product Code
LZA
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
GLOVCO (M) SDN. BHD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A patient examination glove that is worn by the healthcare or similar personnel to prevent contamination between the healthcare personnel and the patient
Device Description
Powder-Free Nitrile Examination Glove, BLUE
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K Number
K994013Device Name
POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (100 MICROGRAMS OR LESS)
Manufacturer
GLOVCO (M) SDN. BHD.
Date Cleared
2000-01-20
(55 days)
Product Code
LYY
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
GLOVCO (M) SDN. BHD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A patient examination glove that is worn by the healthcare or similar personnel to prevent contamination between the healthcare personnel and the patient.
Device Description
Powdered Latex Examination Gloves with Protein and Powder Claim (100 MICROGRAMS OF LESS)
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K Number
K993752Device Name
GLOVCO, POWDER-FREE CHLORINATED LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS)
Manufacturer
GLOVCO (M) SDN. BHD.
Date Cleared
1999-12-03
(28 days)
Product Code
LYY
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
GLOVCO (M) SDN. BHD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A patient examination glove that is worn by the healthcare or similar personnel to prevent contamination between the healthcare personnel and the patient
Device Description
Powder-free Chlorinated Latex Examination Gloves with Protein Labeling Claim
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K Number
K991554Device Name
GLOVCO, POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
Manufacturer
GLOVCO (M) SDN. BHD.
Date Cleared
1999-07-09
(67 days)
Product Code
LYY
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
GLOVCO (M) SDN. BHD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A patient examination glove that is worn by the healthcare or similar personnel to prevent contamination between the healthcare personnel and the patient
Device Description
Powder-free Latex Examination Gloves with Protein Labeling Claim (50 micrograms OR LESS)
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K Number
K991043Device Name
LATEX EXAMINATION GLOVES POWDERED, LOW PROTEIN
Manufacturer
GLOVCO (M) SDN. BHD.
Date Cleared
1999-05-04
(36 days)
Product Code
LYY
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
GLOVCO (M) SDN. BHD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A patient examination glove that is worn by the healthcare or similar personnel to prever t contamination setween the healthcare and the patient.
Device Description
Powdered Latex Examination Gloves with Protein Labeling Claim
Ask a Question
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