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510(k) Data Aggregation
K Number
K100856Device Name
POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
Manufacturer
SUZHOU SHENGYUDA PLASTIC PRODUCTS CO., LTD.
Date Cleared
2010-05-19
(54 days)
Product Code
LYZ
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
SUZHOU SHENGYUDA PLASTIC PRODUCTS CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Powdered 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
Powdered Vinyl Patient Examination Gloves, Clear (non-colored) that meets all of the requirements of ASTM standard D 5250-06e1.
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K Number
K100855Device Name
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
Manufacturer
SUZHOU SHENGYUDA PLASTIC PRODUCTS CO., LTD.
Date Cleared
2010-04-22
(27 days)
Product Code
LYZ, EXA
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
SUZHOU SHENGYUDA 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 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 5250-06e1.
Ask a Question
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