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510(k) Data Aggregation
K Number
K003563Device Name
POWDER-FREE NITRILE EXAM GLOVE, LAVENDER/PURPLE
Manufacturer
NING BO YUJIANG RUBBER & PLASTIC CO.
Date Cleared
2001-01-02
(43 days)
Product Code
LZA
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
**NING BO YUJIANG RUBBER **& PLASTIC CO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K991821Device Name
NITRILE EXAMINATION GLOVE, POWDERED, BLUE
Manufacturer
NING BO YUJIANG RUBBER & PLASTIC CO.
Date Cleared
1999-07-01
(35 days)
Product Code
LZA
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
**NING BO YUJIANG RUBBER **& PLASTIC CO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A 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
The device is powdered Nitrile Exam Gloves. They are non-sterile, single use, disposable gloves.
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