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510(k) Data Aggregation
K Number
K110250Device Name
MPXX POWDER FREE NATURAL RUBBER EXAMINATION GLOVES
Manufacturer
TOTAL GLOVES SDN BHD
Date Cleared
2011-10-14
(259 days)
Product Code
LYY
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
TOTAL GLOVES SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
MPXX™ Powder Free Natural Rubber Latex Examination Gloves are intended for single use for medical purposes that is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient.
Device Description
MPXX™™ Powder Free Natural Rubber Latex Examination Gloves are substantially equivalent to the Class 1 patient examination glove bearing the product code 80LYY ( 21 CFR 880.6250 ). It meets all the current specifications listed under the ASTM Specification D-3578-05, Standard Specification for Rubber Examination Gloves. They are made from natural rubber latex. They are natural white in color and are powder free.
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