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510(k) Data Aggregation
K Number
K183280Device Name
PowderFree White Blue Sterilized Nitrile Copolymer Examination Gloves Tested for use with chemotherapy drugs
Manufacturer
Date Cleared
2019-07-26
(245 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Smart Glove Corporation 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 worn on the examiner's hand or finger to prevent contamination between patient and examiner. Tested for use with chemotherapy drugs as listed below.
Device Description
PowderFree White Blue Sterilized Nitrile Copolymer Examination Gloves Tested for Use with Chemotherapy Drugs.
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