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510(k) Data Aggregation
K Number
K121526Device Name
POWER-FREE NITRILE PATIENT EXAMINATION GLOVES
Manufacturer
SHANDONG JUNCHI MEDICAL PRODUCTS CO., LTD.
Date Cleared
2012-08-03
(72 days)
Product Code
LZA
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
SHANDONG JUNCHI MEDICAL 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
Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Powder-Free Nitrile Patient Examination Glove, 80LZA, and meets all requirement of ASTM Standard D6319-05.
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