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510(k) Data Aggregation
K Number
K211708Device Name
Disposable Medical Nitrile Gloves
Manufacturer
Date Cleared
2021-08-17
(75 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Jiangsu Health-Peace Medical Technology Co. Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Disposable Medical Nitrile Gloves are disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
Device Description
The subject device in this 510(k) Notification is Disposable Medical Nitrile Gloves. The subject device is a patient examination glove made from nitrile compound, blue color, powder free and nonsterile (Per 21 CFR 880.6250, Class I). The device meets the specifications in ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application.
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