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510(k) Data Aggregation
K Number
K032907Device Name
FUGUAN (BRAND) POWDERED VINYL PATIENT EXAMINATION GLOVES
Manufacturer
SHIJIAZHUANG FUGUAN PLASTIC PRODUCTS CO., LTD.
Date Cleared
2003-11-20
(64 days)
Product Code
LYZ
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
SHIJIAZHUANG FUGUAN PLASTIC PRODUCTS CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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, white(non-colored) that meets all of the requirements of ASTM standard D 5250-0064
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K Number
K032908Device Name
FUGUAN (BRAND) POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
Manufacturer
SHIJIAZHUANG FUGUAN PLASTIC PRODUCTS CO., LTD.
Date Cleared
2003-11-20
(64 days)
Product Code
LYZ
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
SHIJIAZHUANG FUGUAN PLASTIC PRODUCTS CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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, white(non-colored) that meets all of the requirements of ASTM standard D 5250-00e4
Ask a Question
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