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Found 4 results
510(k) Data Aggregation
K Number
K100975Device Name
NITRIL EXAM GLOVE, PRE-POWERED COLOR WHITE, NITRILE EXAM GLOVE, PRE-POWDERED, COLOR BLUE
Manufacturer
Date Cleared
2010-08-17
(130 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
JIANGSU SUNSHINE PLASTIC PRODUCTS, CO. LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Device Description
Nitrile Exam Glove, Pre-Powdered, Color White, Blue
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K Number
K100977Device Name
PRE-POWDERED VINYL PATIENT EXAMINATION GLOVE, NON-STERILE
Manufacturer
Date Cleared
2010-08-12
(126 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
JIANGSU SUNSHINE PLASTIC PRODUCTS, CO. LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Device Description
Pre-Powdered Vinyl Patient Examination Glove
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K Number
K100978Device Name
POWDER FREE NON-STERILE VINYL EXAMINATION GLOVE
Manufacturer
Date Cleared
2010-08-12
(126 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
JIANGSU SUNSHINE PLASTIC PRODUCTS, CO. LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Device Description
Powder-Free Non-Sterile Vinyl Examination Glove
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K Number
K100979Device Name
NITRILE EXAM GLOVE, POWDER-FREE MODEL COLOR WHITE, NITRILE EXAM GLOVE, POWDER-FREE MODEL COLOR BLUE
Manufacturer
Date Cleared
2010-07-02
(85 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
JIANGSU SUNSHINE PLASTIC PRODUCTS, CO. LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Device Description
Nitrile Exam Glove, Powder-Free Model Color White, Blue
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Ask a specific question about this device
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