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510(k) Data Aggregation
K Number
K220343Device Name
Nitrile Examination Gloves
Manufacturer
Date Cleared
2022-04-02
(54 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
NB Medical Co., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The NITRILE EXAMINATION GLOVES is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner.
Device Description
The subject device is powder free nitrile examination gloves. The subject device is white, cobalt blue, black, blue. It can be available in six specifications: S, M, L, XL. The subject device is non-sterile.
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