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510(k) Data Aggregation
K Number
K141613Device Name
GOLDENLINE POWDER-FREE WHITE VINYL PATIENT EXAMINATION GLOVES
Manufacturer
Date Cleared
2014-12-04
(171 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
ZIBO GOLDENLINE PLASTIC PRODUCT CO., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Powder Free White Vinyl Patient Examination Gloves is a non sterile 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 White Vinyl Patient Examination Gloves that meets all of the requirements of ASTM standard D 5250-06(Reaffirmation 2011).
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K Number
K083015Device Name
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
Manufacturer
Date Cleared
2009-03-10
(152 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
ZIBO GOLDENLINE PLASTIC PRODUCT 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 hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.
A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or finger to prevent contamination between patient and examiner (21CFR 880.6250)
Device Description
Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Powder-Free Vinyl Patient Examination Glove, 80LYZ, and meets all requirement of ASTM Standard D5250-00.
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