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Found 4 results
510(k) Data Aggregation
K Number
K101358Device Name
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
Manufacturer
Date Cleared
2010-08-24
(102 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
HEBEI HANDFORM PLASTIC PRODUCTS CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Powder free vinyl 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 vinyl patient examination gloves, Colored (White) that meets all of the requirements of ASTM standard D 5250-06.
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K Number
K101362Device Name
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (YELLOW)
Manufacturer
Date Cleared
2010-06-17
(34 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
HEBEI HANDFORM PLASTIC PRODUCTS CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Powder free vinyl 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 vinyl patient examination gloves, Colored (Yellow) that meets all of the requirements of ASTM standard D 5250-06.
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K Number
K082690Device Name
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
Manufacturer
Date Cleared
2009-02-09
(147 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
HEBEI HANDFORM PLASTIC PRODUCTS CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Powder free vinyl 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 vinyl patient examination gloves, Clear(non-colored) that meets all of the requirements of ASTM standard D 5250-06.
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K Number
K082691Device Name
POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
Manufacturer
Date Cleared
2009-02-04
(142 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
HEBEI HANDFORM PLASTIC PRODUCTS CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Powdered vinyl 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
powdered vinyl patient examination gloves, Clear(non-colored) that meets all of the requirements of ASTM standard D 5250-06.
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Ask a specific question about this device
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