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Found 4 results
510(k) Data Aggregation
K Number
K090828Device Name
NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVES
Manufacturer
ULTRAWIN SDN BHD
Date Cleared
2009-07-28
(124 days)
Product Code
LZA
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
ULTRAWIN SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner.
Device Description
Powder Free Nitrile Examination Gloves meets all the current specifications listed under the ASTM Specification D6319-00a, Standard Specification for Nitrile Examination Gloves for medical Application.
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K Number
K072802Device Name
SINGLE USE, DISPOSABLE, BLUE COLOR, POWDER FREE LATEX PATIENT EXAMINATION GLOVE
Manufacturer
ULTRAWIN SDN BHD
Date Cleared
2008-02-29
(151 days)
Product Code
LYY
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
ULTRAWIN SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A non sterile powder free latex exam glove intended for medical purposes that is worn on the examiner's hands to prevent contamination between the patient and examiner.
Device Description
SINGLE USE, DISPOSABLE, BLUE COLOR, POWDER FREE LATEX PATIENT EXAMINATION GLOVE WITH COLLOIDAL OATMEAL USP WITH A PROTEIN CLAIM OF 50 MICROGRAM OR LESS PER GRAM OF GLOVE
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K Number
K992175Device Name
EXTRA-CARE LATEX PATIENT EXAMINATION GLOVE, POWDER-FREE, POLYMER COATED
Manufacturer
ULTRAWIN SDN BHD
Date Cleared
1999-09-24
(88 days)
Product Code
LYY
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
ULTRAWIN SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A patient examination glove is a disposable device intended for medical purposes worn on the examiner's hand to prevent contamination between patient and examiner.
Device Description
Extra-Care Powder Free Latex Patient Examination Glove - Polymer Coated
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K Number
K983175Device Name
EXTRA-CARE POWDER-FREE EXAMINATION GLOVE
Manufacturer
ULTRAWIN SDN BHD
Date Cleared
1998-10-13
(33 days)
Product Code
LYY
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
ULTRAWIN SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A patient examination glove is a disposable device intended for medical purposes worn on the examiner's hand to prevent contamination between patient and examiner.
Device Description
Extra-Care Latex Powder-Free Examination Glove
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