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510(k) Data Aggregation
K Number
K101870Device Name
SUNMAX VIETNAM CO. LTD POWDER FREE WHITE NITRILE EXAMINATION GLOVE
Manufacturer
Date Cleared
2010-12-20
(167 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
SUNMAX VIETNAM CO. LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A powder free patient examination glove is a disposable device intended for medical purposes that is worn on the examiners hand or finger to prevent contamination between patient and examiner.
Device Description
Sunmax Vietnam Co. Ltd Powder free Nitrile Examination Glove is a class I device having product code 80LZA. It is a disposable device that meets all requirements of ASTM D 631900a-05.
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