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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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