FDA 510(k) Applications Submitted by Robert Mahler

FDA 510(k) Number Submission Date Device Name Applicant
K160399 02/12/2016 Skyn Original Polyisoprene Lubricated Male Condom Ansell Healthcare Products, LLC
K160974 04/07/2016 Gammex Cut-Resistant Glove Liner ANSELL HEALTHCARE PRODUCTS LLC
K171172 04/21/2017 Skyn Original Polyisoprene Lubricated Male Condom - Flavored 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
K172473 08/15/2017 LifeStyles« SKYN« Intimate Moments Personal Lubricant SXWELL USA LLC
K182438 09/07/2018 Synthetic Polyisoprene Lubricated Male Condom - 5 senses Sxwell Usa LLC
K163107 11/07/2016 Lifestyles Zero Lubricated Latex Male Condom ANSELL HEALTHCARE PRODUCTS, LLC


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