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

FDA 510(k) Number	Submission Date	Device Name	Applicant
K160928	04/04/2016	Latex Polymer Coated Powder Free Surgical Glove with Protein Labeling Claim of 50 microgram or Less per Gram of Glove (Natural), Latex Polymer Coated Powder Free Surgical Glove with Protein Labeling Claim of 50 microgram or Less per Gram of Glove (Green)	HARTALEGA SDB. BHD.
K142270	08/15/2014	LATEX POWDERED EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM OF 200 MICROGRAM OR LESS PER GRAM OF GLOVE	HARTALEGA SDB. BHD.
K142805	09/29/2014	Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant Drug- Dark Violet Blue (DVBU)	HARTALEGA SDB. BHD.
K162924	10/18/2016	Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs (White); Dark Violet Blue (DVBU); Dark Blue (DKBU)	HARTALEGA SDB. BHD.