FDA 510(k) Applications Submitted by PT. MEDISAFE TECHNOLOGIES

FDA 510(k) Number Submission Date Device Name Applicant
K030228 01/22/2003 POWDERFREE POLYCHLOROPRENE STERILIZED SURGICAL GLOVES PT. MEDISAFE TECHNOLOGIES
K010483 02/20/2001 POWDERFREE COLORED LATEX EXAMINATION GLOVES (PINK, BLUE, GREEN, AND WHITE) WITH PROTEIN CONTENT LABELING CLAIM (50 MICR0 PT. MEDISAFE TECHNOLOGIES
K010486 02/20/2001 POLYMER COATED POWDER-FREE GREY COLOR POLYCHLOROPRENE PATIENT EXAMINATION GLOVES PT. MEDISAFE TECHNOLOGIES
K040607 03/08/2004 MODIFICATION TO POWDERFREE COLORED AND FLAVORED CHLOROPRENE PATIENT EXAMINATION GLOVES PT. MEDISAFE TECHNOLOGIES
K050968 04/18/2005 POWDERFREE POLYCHLOROPRENE STERILE EXAMINATION GLOVES PT. MEDISAFE TECHNOLOGIES
K041913 07/15/2004 POWDERFREE COLORED AND FLAVORED CHLOREPRENE PATIENT EXAMINATION GLOVES TESTED FOR CHEMO USE PT. MEDISAFE TECHNOLOGIES
K082302 08/12/2008 POWDER FREE NITRILE PATIENT EXAMINATION GLOVES WITH CHEMO LABELING CLAIM PT. MEDISAFE TECHNOLOGIES
K112654 09/12/2011 POWDERFREE POLYISOPRENE SURGICAL GLOVES PT. MEDISAFE TECHNOLOGIES
K102620 09/13/2010 POWDERFREE BLACK NITRILE EXAMINATION GLOVES PT. MEDISAFE TECHNOLOGIES
K102623 09/13/2010 BLUE POWDERFREE NITRILE EXAMINATION GLOVE PT. MEDISAFE TECHNOLOGIES
K042567 09/21/2004 POWDERFREE POLYCHLOROPRENE STERILIZED SURGICAL GLOVES WITH ALOE VERA AND VITAMIN E PT. MEDISAFE TECHNOLOGIES
K033086 09/29/2003 NEOSOOTHE POLYMER COATED POWDER-FREE POLYCHLOROPRENE PATIENT EXAMINATION GLOVES WITH ALOE PT. MEDISAFE TECHNOLOGIES
K133689 12/02/2013 POWDER FREE POLYCHLOROPRENE LIGHT WIEGHT EXAMINATIONGLOVES- GREEN,BLUE AND PINK PT. MEDISAFE TECHNOLOGIES
K173258 10/10/2017 Polychloroprene Powder Free Sterile Surgical Gloves, White, Tested for Use with Chemotherapy Pt. Medisafe Technologies
K163041 10/31/2016 Powder Free Polychloroprene Examination Gloves-Pink with Aloe Vera and Vitamin E PT. MEDISAFE TECHNOLOGIES
K201774 06/29/2020 Polychloroprene Powder Free Sterile Surgical Gloves, Low Dermatitis Potential and Tested for Use with Chemotherapy Drugs PT. Medisafe Technologies
K182176 08/10/2018 Polychloroprene Powder Free Sterile Surgical Gloves, White, Tested for Use with Chemotherapy Drugs PT. Medisafe Technologies


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