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510(k) Data Aggregation
K Number
K181106Device Name
Powder Free Nitrile Patient Examination Gloves, Blue Color
Manufacturer
JiangSu DongXin Medical Technology Co., Ltd
Date Cleared
2019-01-16
(265 days)
Product Code
LZA
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
JiangSu DongXin Medical Technology Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Powder Free Nitrile Patient Examination Gloves, Blue Color 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
The proposed device is Powder Free Nitrile Examination Gloves. The proposed device is blue. The proposed device is non-sterile.
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