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510(k) Data Aggregation
K Number
K133325Device Name
BLUE NITRILE POWDER FREE EXAM GLOVES
Manufacturer
Date Cleared
2014-08-08
(283 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
SHANDONG XINSHI MEDICAL PRODUCTS 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 upon the examiner's hands of fingers to prevent contamination between patient and examiner.
Device Description
Classified by FDA's General and Plastic Surgery Device panel as Class 1, 21 CFR 880.6250, Powder-Free Nitrile Patient Examination Glove. 80LZA, and meets all requirement of ASTM Standard D6319-10.
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