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510(k) Data Aggregation
K Number
K213775Device Name
Glovatex White Latex Gloves, Glovanil Blue Nitrile Gloves
Manufacturer
Date Cleared
2022-04-24
(143 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Avecena Gloves Sdn Bhd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Glovatex™ White Latex Glove is a disposable device intended for Medical purpose that is worn on the examiner's hands or finger to prevent contamination patient and examiner.
The Glovanil™ Blue Nittile Glove is a disposable device intended for Medical purpose that is worn on the examiner's hands or finger to prevent contamination patient and examiner.
Device Description
Glovatex™ White Latex Gloves are manufactured to meet all the current specifications listed under the ASTM Specification D 3578-05 (Reapproved 2015), Standard Specification for Rubber Examination Gloves. They are made from Natural Rubber Latex. These gloves are in white color, non-sterile and powder free.
Glovanil™ Blue Nitrile Gloves are manufactured to meet all the current specifications listed under the ASTM Specification ASTM D6319 - 19 Standard Specification for Nitrile Examination Gloves for Medical Application. They are made from Nitrile compound. These gloves are in Blue color, non-sterile and powder free.
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