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Found 5 results
510(k) Data Aggregation
K Number
K091965Device Name
POWDER FREE NITRILE EXAMINATION GLOVES BLACK; BLUE, GRAPE SCENTED
Manufacturer
Date Cleared
2009-11-24
(146 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
PLATINUM GLOVE INDUSTRIES SDN.BHD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
This glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Device Description
Powder Free Nitrile Examination Gloves, Black Powder Free Nitrile Examination Gloves, Blue, Grape Scented
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K Number
K080165Device Name
SMART SAVERS POWDER FREE NITRILE EXAMINATION GLOVE (BLUE, WHITE, PINK AND GRAY)
Manufacturer
Date Cleared
2008-05-14
(112 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
PLATINUM GLOVE INDUSTRIES SDN.BHD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
This glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Device Description
Smart Savers, Powder Free Nitrile Examination Gloves, Blue, White, Pink and Gray color
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K Number
K051372Device Name
POWDER FREE NITRILE EXAMINATION GLOVES WITH PEPPERMINT SCENTED (BLUE COLOR)
Manufacturer
Date Cleared
2005-07-07
(42 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
PLATINUM GLOVE INDUSTRIES SDN.BHD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
This glove is disposable and intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
Device Description
Powder Free Nitrile Examination Gloves With Peppermint Scented (Blue Color)
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K Number
K051317Device Name
POLYMER COATED POWDER FREE NITRILE EXAMINATION GLOVES, BLUE, GREEN AND WHITE COLOR
Manufacturer
Date Cleared
2005-06-20
(31 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
PLATINUM GLOVE INDUSTRIES SDN.BHD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
This glove is disposable and intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
Device Description
Polymer Coated Powder Free Nitrile Examination Gloves, Blue, Green and White color.
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K Number
K051318Device Name
POWDER FREE NITRILE EXAMINATION GLOVES (WHITE, BLUE, AND PURPLE COLOR)
Manufacturer
Date Cleared
2005-06-17
(28 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
PLATINUM GLOVE INDUSTRIES SDN.BHD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
This glove is disposable and intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
Device Description
Powder Free Nitrile Examination Gloves (White, Blue and Purple Color)
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