FDA 510(k) Applications Submitted by HARTALEGA SDN BHD

FDA 510(k) Number Submission Date Device Name Applicant
K954221 09/11/1995 POLYMER COATED CHLORINATED POWDER-FREE LATEX EXAMINATION GLOVES HARTALEGA SDN BHD
K993725 11/03/1999 GREEN CHLORINATED POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM OF 50 MICROGRAMS OR LESS HARTALEGA SDN BHD
K963804 09/23/1996 PATIENT EXAMINATION GLOVES : NITRILE EXAMINATION GLOVES HARTALEGA SDN BHD
K973778 10/03/1997 POLYMER COATED POWDER-FREE LATEX EXAMINATION GLOVES HARTALEGA SDN BHD
K150103 01/20/2015 Nitrile Powder Free Examination Gloves (Orange) Tested For Use With Chemotherapy Drugs 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
K051777 07/01/2005 NITRILE POWDER FREE EXAMINATION GLOVES (BLUE) HARTALEGA SDN BHD
K051778 07/01/2005 NITRILE POWDERED 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
K050214 01/31/2005 NITRILE POWDER FREE EXAMINATION GLOVES (WHITE) HARTALEGA SDN BHD
K050215 01/31/2005 NITRILE POWDERED EXAMINATION GLOVES (WHITE) 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
K954415 09/21/1995 PATIENT EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM HARTALEGA SDN BHD
K954416 09/21/1995 POLYMER COATED POWDER-FREE LATEX EXAMINATION GLOVES 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
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
K150593 03/09/2015 Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue) HARTALEGA SDN BHD
K180644 03/12/2018 Nitrile Powder Free Examination Gloves with Colloidal Oatmeal - Lemon Green Hartalega Sdn Bhd
K180645 03/12/2018 Powder Free Examination Gloves with Colloidal Oatmeal USP and Tested for Use with Chemotherapy Drugs - (Lemon Green) Hartalega Sdn Bhd
K001959 06/27/2000 POWDERED STERILE LATEX SURGICAL GLOVE, WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS) HARTALEGA SDN BHD
K140050 01/09/2014 NITRILE POWDER FREE EXAMINATION GLOVE WITH COLLOIDAL OATMEAL USP SKIN PROTECTANT DRUG - DKBU /DARK BLUE HARTALEGA SDN BHD
K120336 02/03/2012 NITRILE POWDER FREE EXAMINATION GLOVES (VIO) TESTED FOR USE WITH CHENITRILE POWDER FREE EXAMINATION (ABLU) TESTED FOR U HARTALEGA SDN BHD
K052177 08/10/2005 POWDER FREE STERILE LATEX SURGICAL GLOVES HARTALEGA SDN BHD
K123368 11/01/2012 LATEX POWDER FREE EXAMINATION GLOVES WITH COLLOIDAL OATMEAL USP SKIN PROTECTANT HARTALEGA SDN BHD
K002593 08/21/2000 POWDER FREE STERILE LATEX SURGICAL GLOVES, CONTAINS 50 MICROGRAM OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GRAM HARTALEGA SDN BHD
K063046 10/04/2006 NITRILE POWDER FREE EXAMINATION GLOVES (GREEN) HARTALEGA SDN BHD
K050277 02/07/2005 CHLORINATED POWDER FREE LATEX EXAMINATION GLOVES (YELLOW) HARTALEGA SDN BHD
K132006 07/01/2013 STERILE NITRILE POWDER FREE EXAMINATION GLOVE(VBLU), STERLE NITRILE POWDER FREE EXAMINATION GLOVE(ABLU) HARTALEGA SDN BHD
K133956 12/23/2013 NITRILE POWDER FREE EXAMINATION GLOVE WITH COLLOIDAL OATMEAL USP SKIN PROTECTANT DRUG - WHITE / DAWN BLUE / LEMON GREEN HARTALEGA SDN BHD
K130473 02/22/2013 NITRILE POWDER FREE EXAMINATION GLOVE (ABLU) HARTALEGA SDN BHD
K110758 03/18/2011 NITRILE POWDER FREE EXAMINATION GLOVES HARTALEGA SDN BHD
K091652 06/09/2009 NITRILE POWDER FRE EXAMINATION GLOVES (BLUE) TESTED FOR USE WITH CHEMOTHREAPY DRUGS HARTALEGA SDN BHD
K071910 07/11/2007 NITRILE POWDER FREE EXAMINATION GLOVES (BLUE), NITRILE POWDER FREE EXAMINATION GLOVES (PINK) HARTALEGA SDN BHD
K133953 12/23/2013 LATEX POWDER FREE EXAMINATION GLOVES WITH COLLOIDAL OATMEAL USP SKIN PROTECTANT DRUG WITH PROTEIN LABELING CLAIM OF 50 M HARTALEGA SDN BHD
K041391 05/25/2004 FREEFORM BLUE POWDER-FREE NITRILE EXAMINATION GLOVES HARTALEGA SDN BHD
K022671 08/12/2002 FREEFORM BLUE POWDERFREE NITRILE EXAMINATION GLOVES HARTALEGA SDN BHD


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