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510(k) Data Aggregation
K Number
K091429Device Name
VINYL POWDER FREE EXAMINATION GLOVE
Manufacturer
Date Cleared
2009-07-22
(70 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
SHUN DA (XINGHUA) CO., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A patient examination Vinyl Powder Free Examination Glove is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
Device Description
Vinyl Powder Free Examination Glove
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K Number
K091427Device Name
VINYL POWDERED EXAMINATION GLOVE
Manufacturer
Date Cleared
2009-06-23
(41 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
SHUN DA (XINGHUA) CO., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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