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510(k) Data Aggregation
K Number
K141108Device Name
YUSHENG
Manufacturer
ZIBO YUSHENG PLASTIC PRODUCTS CO., LTD.
Date Cleared
2014-09-16
(140 days)
Product Code
LYZ
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
ZIBO YUSHENG PLASTIC PRODUCTS CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) 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 Vinyl Patient Examination Gloves, Clear (Non-colored) that meets all of the requirements of ASTM standard D 5250-06(Reaffirmation 2011).
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K Number
K091431Device Name
POWDER-FREE, YELLOW VINYL PATIENT EXAMINATION GLOVES
Manufacturer
ZIBO YUSHENG PLASTIC PRODUCTS CO., LTD.
Date Cleared
2009-07-08
(56 days)
Product Code
LYZ
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
ZIBO YUSHENG PLASTIC PRODUCTS CO., LTD.
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 upon the examiner's hands or finger to prevent contamination between patient and examiner (21CFR 880.6250)
Device Description
Patient Vinyl Examination Gloves, Yellow, Powder free, Non-Sterile
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