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510(k) Data Aggregation
K Number
K121844Device Name
POWDER FREE NATURAL RUBBER LATEX EXAMINATION GLOVES
Manufacturer
WORLDMED MANUFACTURING SDN. BHD.
Date Cleared
2013-09-06
(438 days)
Product Code
LYY
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
WORLDMED MANUFACTURING SDN. BHD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Powder Free Natural Rubber Latex Examination Gloves is a single use disposable device intended for medical purposes that is worn on the hands of healthcare and similar personnel to prevent contamination between the healthcare personnel and the patient.
Device Description
The Powder Free Natural Rubber Latex Examination Gloves meets all the requirements of ASTM Specification D3578-05(2010) Standard Specification for Rubber Examination Gloves standard.
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K Number
K123116Device Name
CHLORINATED POWDER FREE NITRILE EXAMINATION GLOVES (BLACK COLOUR)
Manufacturer
WORLDMED MANUFACTURING SDN. BHD.
Date Cleared
2013-02-11
(131 days)
Product Code
LZA
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
WORLDMED MANUFACTURING SDN. BHD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Chlorinated Powder Free Nitrile Examination Gloves (Black Colour) is a single use device intended for medical purposes that is worn on the hand of healthcare and similar personnel to prevent contamination between the healthcare personnel and the patient.
Device Description
The Chlorinated Powder Free Nitrile Examination Gloves (Black Colour) meets all the Nitrile requirements of ASTM Specification D6319-10 Standard Specification for Examination Gloves for Medical Application.
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