POWDER FREE NATURAL RUBBER LATEX EXAMINATION GLOVES

Latex Patient Examination Glove

WORLDMED MANUFACTURING SDN. BHD.

The following data is part of a premarket notification filed by Worldmed Manufacturing Sdn. Bhd. with the FDA for Powder Free Natural Rubber Latex Examination Gloves.

Pre-market Notification Details

Device IDK121844
510k NumberK121844
Device Name:POWDER FREE NATURAL RUBBER LATEX EXAMINATION GLOVES
ClassificationLatex Patient Examination Glove
Applicant WORLDMED MANUFACTURING SDN. BHD. LOT 18873, JALAN PERUSAHAAN 3, KAMUNTING INDUSTRIAL ESTATE Kamunting,  MY 34600
ContactChandrasegaran
CorrespondentChandrasegaran
WORLDMED MANUFACTURING SDN. BHD. LOT 18873, JALAN PERUSAHAAN 3, KAMUNTING INDUSTRIAL ESTATE Kamunting,  MY 34600
Product CodeLYY  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-06-25
Decision Date2013-09-06
Summary:summary

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