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510(k) Data Aggregation
K Number
K212014Device Name
Medical Nitrile Examination Gloves
Manufacturer
Date Cleared
2021-10-13
(107 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Jiangxi Ronglai Medical Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Medical Nitrile Examination Gloves is a 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 a powder free medical glove. The device is blue in color. The device meets the requirements of ASTM D6319-19: Standard specification for Nitrile Examination Gloves for Medical Application. The proposed gloves are available in six sizes, which are XS, S, M, L, XL, XXL, it could be selected by the user depended on size of hand. The different between each size is just in the dimension. The proposed device is provided in non-sterile.
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