FDA 510(k) Applications Submitted by PERUSAHAAN GETAH ASAS SDN BHD

FDA 510(k) Number Submission Date Device Name Applicant
K980916 03/11/1998 POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM PERUSAHAAN GETAH ASAS SDN BHD
K982440 07/14/1998 NITRILE PATIENT EXAMINATION GLOVE PERUSAHAAN GETAH ASAS SDN BHD
K982806 08/11/1998 CHLORINATED, POLYMER COATED, POWDER-FREE LATEX EXAMINATION GLOVE PERUSAHAAN GETAH ASAS SDN BHD
K982807 08/11/1998 POLYMER COATED, POWDER-FREE LATEX EXAMINATION GLOVE PERUSAHAAN GETAH ASAS SDN BHD
K983729 10/22/1998 POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE PERUSAHAAN GETAH ASAS SDN BHD
K984356 12/07/1998 NITRILE PATIENT EXAMINATION GLOVE, BLUE OR GREEN COLORED (PREPOWDERED USP) PERUSAHAAN GETAH ASAS SDN BHD
K030331 01/31/2003 ON-LINE POWDER-FREE LATEX EXAMINATION GLOVE, TYPE II,LOW MODULUS, WITH PROTEIN LABELING CLAIM PERUSAHAAN GETAH ASAS SDN BHD
K030333 01/31/2003 LATEX EXAMINATION GLOVE,POWEDERED TYPE II, LOW MODULUS,WITH PROTEIN LABLING CLAIM PERUSAHAAN GETAH ASAS SDN BHD
K030335 01/31/2003 ON-LINE POWDER-FREE NITRILE EXAMINATION GLOVE, VIOLET COLORED PERUSAHAAN GETAH ASAS SDN BHD
K031021 03/31/2003 CHLORINATED, POLYMER COATED, POWDER-FREE LATEX EXAMINATION GLOVE PERUSAHAAN GETAH ASAS SDN BHD
K031414 05/05/2003 POWDER-FREE LATEX PATIENT EXAMINATION GLOVE, WHITE (NON-COLORED), OR BLUE COLORED, WITH EXTRACTABLE PROTEIN CONTENT LABE PERUSAHAAN GETAH ASAS SDN BHD
K031591 05/21/2003 POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, WHITE (NON-COLORED), BLUE AND GREEN COLORED PERUSAHAAN GETAH ASAS SDN BHD
K031625 05/27/2003 POWDER-FREE BARRIER-PRO CO-POLYMER EXAMINATION GLOVE, WHITE (NON-COLORED), AND GREEN COLORED PERUSAHAAN GETAH ASAS SDN BHD
K031768 06/09/2003 BARRIER-PRO CO-POLYMER PATIENT EXAMINATION GLOVE, POWDERED, WHITE (NON-COLORED) OR GREEN COLORED PERUSAHAAN GETAH ASAS SDN BHD
K032374 08/01/2003 POWDER-FREE NITRILE PATIENT CHEMOTHERAPY EXAMINATION GLOVE, BLUE COLORED PERUSAHAAN GETAH ASAS SDN BHD
K022601 08/05/2002 POWDER-FREE LATEX EXAMINATION GLOVE (SURFACE TREATED WITH ALOE VERA GEL) PERUSAHAAN GETAH ASAS SDN BHD
K024184 12/19/2002 POWDER-FREE COATED NITRILE EXAMINATION GLOVE, BLUE COLORED PERUSAHAAN GETAH ASAS SDN BHD
K042805 10/12/2004 POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE COLORED NON-STERILE PERUSAHAAN GETAH ASAS SDN BHD
K010719 03/12/2001 POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, PURPLE COLOR PERUSAHAAN GETAH ASAS SDN BHD
K102790 09/27/2010 POWDER FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE COLORED NON-STERILE (LOW DERAMATITIS POTENTIAL AND CHEMOTHERAPY DRUG PERUSAHAAN GETAH ASAS SDN BHD
K011271 04/26/2001 POWDER-FREE LATEX EXAMINATION GLOVE, BLUE COLORED PERUSAHAAN GETAH ASAS SDN BHD
K001529 05/17/2000 POLYMER COATED, POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN LABELLING CLAIM, CONTAINS 50 MICROGRAMS OR LESS OF TOTA PERUSAHAAN GETAH ASAS SDN BHD
K002314 07/31/2000 LATEX PATIENT EXAMINATION GLOVES POWDERED WITH PROTEIN CONTENT LABELING CLAIM; 100 MICROGRAM OR LESS OF TOTAL WATER EXTR PERUSAHAAN GETAH ASAS SDN BHD
K022701 08/14/2002 POWDER-FREE, LATEX EXAMINATION GLOVE COATED WITH ALOE VERA GEL AND VITAMIN E PERUSAHAAN GETAH ASAS SDN BHD
K003737 12/04/2000 POWDERED LATEX PATIENT EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMSPER OR LESS) PERUSAHAAN GETAH ASAS SDN BHD
K984605 12/28/1998 POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, WHITE (NON COLORED) PERUSAHAAN GETAH ASAS SDN BHD
K991511 04/30/1999 POWDERED NITRILE EXAMINATION GLOVE, WHITE (NON-COLORED) PERUSAHAAN GETAH ASAS SDN BHD
K023262 09/30/2002 POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN LABELING CLAIM (200 MICROGRAM PER GRAM OF GLOVE OR LESS) PERUSAHAAN GETAH ASAS SDN BHD


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