FDA 510(k) Applications Submitted by Hartalega SDN. BHD.

FDA 510(k) Number Submission Date Device Name Applicant
K171874 06/23/2017 Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant and Tested for Use With Chemotherapy Drugs (Dawn Blue) HARTALEGA SDN. BHD.
K180505 02/26/2018 Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP with Low-Dermatitis Potential Claim and Tested For Use with Chemotherapy Drugs (White) Hartalega Sdn. Bhd.
K180786 03/26/2018 Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs Aqua Blue (ABLU), Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs Violet Blue (VBLU) - Extended Cuff HARTALEGA SDN. BHD.
K200897 04/03/2020 Polyisoprene Powder Free Surgical Underglove for Use with Chemotherapy Drugs (Blue), Polyisoprene Powder Free Surgical Glove for Use with Chemotherapy Drugs (Natural) Hartalega SDN. BHD.
K161006 04/11/2016 Latex Powder Free Polymer Coated Examination Glove with Protein Labeling Claim of 50 Microgram or Less Per Gram of Glove HARTALEGA SDN. BHD.
K161008 04/11/2016 POLYISOPRENE POWDER FREE SURGICAL UNDERGLOVE, POLYISOPRENE POWDER FREE SURGICAL GLOVE HARTALEGA SDN. BHD.
K201531 06/08/2020 Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) Hartalega SDN. BHD.
K162491 09/07/2016 Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue) HARTALEGA SDN. BHD.
K173137 09/29/2017 Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Pink) Hartalega Sdn. Bhd.
K162818 10/06/2016 Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs (Blue) HARTALEGA SDN. BHD.
K162819 10/06/2016 Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Tested for Use with Chemotherapy Drugs HARTALEGA SDN. BHD.
K173509 11/13/2017 Biodegradable Nitrile Powder Free Examination Glove (Blue) Hartalega Sdn. Bhd.


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