FDA 510(k) Applications Submitted by Kuan Kam Hon

FDA 510(k) Number Submission Date Device Name Applicant
K150103 01/20/2015 Nitrile Powder Free Examination Gloves (Orange) Tested For Use With Chemotherapy Drugs HARTALEGA SDN BHD
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.
K201748 06/26/2020 Latex Powder Free Surgical Glove with Protein Labelling Claim of 50 Microgram or Less per Gram of Glove and Tested for use with Chemotherapy Drugs Hartalega SDN BHD
K051778 07/01/2005 NITRILE POWDERED EXAMINATION GLOVES (BLUE) HARTALEGA SDN BHD
K051777 07/01/2005 NITRILE POWDER FREE EXAMINATION GLOVES (BLUE) HARTALEGA SDN BHD
K142588 09/15/2014 Nitrile Powder Free Examination Glove (Blue) HARTALEGA SDN BHD
K052583 09/20/2005 BLUE POWDER FREE NITRILE EXAMINATION GLOVES HARTALEGA SDN BHD
K973871 10/10/1997 LOW POWDER POLYMER LATEX EXAMINATION GLOVES (WITH PROTEIN LABELING CLAIM) HARTALEGA SDN BHD
K062950 09/29/2006 POWDER FREE STERILE NITRILE SURGICAL GLOVES (BLUE) HARTALEGA SDN BHD
K980318 01/27/1998 POWDER-FREE LATEX EXAMINATION GLOVES (BLUE) HARTALEGA SDN BHD
K990283 01/29/1999 BLUE POWDER-FREE NITRILE EXAMINATION GLOVES HARTALEGA SDN BHD
K980572 02/17/1998 POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (GREEN) HARTALEGA SDN BHD
K991616 05/10/1999 CHLORINATED POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) HARTALEGA SDN BHD
K954416 09/21/1995 POLYMER COATED POWDER-FREE LATEX EXAMINATION GLOVES HARTALEGA SDN BHD
K954415 09/21/1995 PATIENT EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM HARTALEGA SDN BHD
K964148 10/16/1996 PATIENT EXAMINATION GLOVES; CHLORINATED POWDERFREE NITRILE EXAMINATION GLOVES HARTALEGA SDN BHD
K993722 11/03/1999 BLUE CHLORINATED POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM OF 50 MICROGRAMS OR LESS. HARTALEGA SDN BHD
K993760 11/08/1999 POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM OF 200 MICROGRAMS OR LESS HARTALEGA SDN BHD
K170152 01/17/2017 POLYCHLOROPRENE POWDER FREE SURGICAL GLOVE (GREEN) HARTALEGA SDN BHD
K190454 02/25/2019 Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Blue), Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Blue) - Extended Cuff Hartalega Ngc 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.
K160560 02/29/2016 Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs (Blue) HARTALEGA SDN BHD
K160562 02/29/2016 Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Tested for Use with Chemotherapy Drugs HARTALEGA SND. BHD.
K150593 03/09/2015 Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue) 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.
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.
K161008 04/11/2016 POLYISOPRENE POWDER FREE SURGICAL UNDERGLOVE, POLYISOPRENE POWDER FREE SURGICAL GLOVE 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.
K201531 06/08/2020 Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) Hartalega SDN. 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.
K162491 09/07/2016 Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue) HARTALEGA SDN. BHD.
K142805 09/29/2014 Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant Drug- Dark Violet Blue (DVBU) HARTALEGA SDB. BHD.
K173137 09/29/2017 Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Pink) 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.
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.
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.
K173509 11/13/2017 Biodegradable Nitrile Powder Free Examination Glove (Blue) Hartalega Sdn. Bhd.


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact