FDA 510(k) Applications Submitted by HARTALEGA SND. BHD.

FDA 510(k) Number Submission Date Device Name Applicant
K160562 02/29/2016 Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Tested for Use with Chemotherapy Drugs HARTALEGA SND. BHD.
K112976 10/06/2011 NITRILE POWDER FREE EXAMINATION GLOVES (WHITE) WITH COLLOIDAL OATM HARTALEGA SND. BHD.


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