FDA 510(k) Applications Submitted by PT. SMART GLOVE INDONESIA

FDA 510(k) Number Submission Date Device Name Applicant
K101293 05/10/2010 POWDER FREE NITRILE EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS (BLUE) PT. SMART GLOVE INDONESIA
K101630 06/10/2010 POWDER FREE NITRILE EXAMINATION GLOVES (6MIL), TESTED FOR USE WITH CHEMOTHERAPY DRUGS (BLUE PT. SMART GLOVE INDONESIA
K041848 07/08/2004 POLYMER COAT POWDER FREE NITRILE EXAMINATION GLOVES, GREEN AND WHITE COLOR PT. SMART GLOVE INDONESIA
K022814 08/26/2002 MULTIPLE NITRILE EXAMINATION GLOVES (POWDERED) PT. SMART GLOVE INDONESIA
K022815 08/26/2002 MULTIPLE PATIENT EXAMINATION GLOVES POWDERED LATEX PT. SMART GLOVE INDONESIA
K030112 01/13/2003 POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM LESS THAN 50 MICROGRAM OR LESS OF TOTAL WATER EXTRACTAB PT. SMART GLOVE INDONESIA
K030406 02/07/2003 NITRILE POWDER FREE EXAM GLOVE, WITH PEPPERMINT FLAVOR PT. SMART GLOVE INDONESIA
K040791 03/29/2004 POLYMER COAT, POWDER FREE NITRILE EXAMINATION GLOVE (BLUE) PT. SMART GLOVE INDONESIA
K040792 03/29/2004 POLYMER COATED, POWDER FREE LATEX EXAMINATION GLOVE (WHITE) PT. SMART GLOVE INDONESIA
K133699 12/03/2013 POWDER FREE GREEN, BLUE AND BROWN POLYCHLOROPRENE EXAMINATION GLOVES PT. SMART GLOVE INDONESIA
K092034 07/06/2009 POWDER FREE NITRILE EXAMINATION GLOVES, BLACK PT. SMART GLOVE INDONESIA


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