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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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