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510(k) Data Aggregation
K Number
K131344Device Name
POWDER FREE YELLOW SYNTHETIC VINYL PATIENT EXAMINATION GLOVES
Manufacturer
Date Cleared
2014-01-30
(266 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
SHIJIAZHUANG WALLY PLASTICS CO., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Powder Free Yellow Synthetic Vinyl Patient Examination Gloves is a disposable device intended for medical purposes that is worn on the examiner's hand or linger to prevent comamination between patient and examiner.
Device Description
Powder Free Yellow Synthetic Vinyl Patient Examination Gloves that meets all of the requirements of ASTM standard D 5250-06(Reaffirmation 2011).
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K Number
K041379Device Name
PRE-POWDERED VINYL EXAM GLOVES
Manufacturer
Date Cleared
2004-08-31
(99 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
SHIJIAZHUANG WALLY PLASTICS CO., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A patient examination glove is a disposable device intended for medical purpose worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Device Description
Vinyl Examination Gloves, Powdered
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K Number
K022600Device Name
POWDER FREE SYNTHETIC VINYL EXAMINATION GLOVES
Manufacturer
Date Cleared
2002-09-16
(42 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
SHIJIAZHUANG WALLY PLASTICS CO., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
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
Synthetic Powder Free Vinyl Patient Exam Gloves
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