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510(k) Data Aggregation
K Number
K203512Device Name
Powder Free Blue Nitrile Examination Glove
Manufacturer
Date Cleared
2021-04-26
(147 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
VIP Glove SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A patient examination glove 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
POWDER FREE BLUE NITRILE EXAMINATION GLOVE
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