FDA 510(k) Applications Submitted by Ansell Healthcare Products LLC

FDA 510(k) Number Submission Date Device Name Applicant
K092327 08/04/2009 MICRO-TOUCH NITRA FREE ANSELL HEALTHCARE PRODUCTS LLC
K093523 11/13/2009 MICRO-TOUCH NITRILE ANSELL HEALTHCARE PRODUCTS LLC
K210401 02/10/2021 Microflex Nitrile Patient Examination Gloves Blue Colored Tested for Use with Chemotherapy Drugs and Fentanyl Citrate, Microflex Nitrile Patient Examination Gloves Green Colored Tested for Use with Chemotherapy Drugs and Fentanyl Citrate, Microflex Nitril Ansell Healthcare Products LLC
K200671 03/13/2020 Microflex Nitrile Patient Examination Gloves with Aloe and Chamomile Blue Green Pink Colored Tested for Ansell Healthcare Products LLC
K212148 07/09/2021 Non-Sterile Powder-Free Polychloroprene Examination Glove (Blue) Tested for Use with Chemotherapy Drugs Ansell Healthcare Products LLC
K122720 09/05/2012 LIFESTYLES WARM LOVIN PERSONAL LUBRICANT ANSELL HEALTHCARE PRODUCTS LLC
K122477 08/14/2012 LIFESTYLES LUXE PREMIUM PERSONAL LUBRICANT ANSELL HEALTHCARE PRODUCTS LLC
K080536 02/27/2008 MICRO-TOUCH NITRAFREE ANSELL HEALTHCARE PRODUCTS LLC
K070800 03/23/2007 LIFESTYLES LUBRICATED POLYISOPRENE LATEX MALE CONDOM ANSELL HEALTHCARE PRODUCTS LLC
K043508 12/20/2004 DERMA PRENE ULTRA POWDER-FREE POLYCHLOROPRENE SYNTHETIC SURGICAL GLOVES (CHEMOTHERAPY USE) ANSELL HEALTHCARE PRODUCTS LLC
K160974 04/07/2016 Gammex Cut-Resistant Glove Liner ANSELL HEALTHCARE PRODUCTS LLC
K171375 05/10/2017 Gammex PI Breach Detect Powder Free Surgical Glove Ansell Healthcare Products LLC
K171737 06/12/2017 Micro Touch Denta Glove Nitrile Hydrasoft Patient Examination Gloves Ansell Healthcare Products LLC


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact