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Ansell Healthcare Products, LLC

FDA 510(k) & PMA Approved Devices — 14 products

Total Devices14
Categories4
Latest FDA decision2023-08-23
TypeNumberDevice NameCodeDateActions
510(k) K230079 Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs and Low Dermatitis PotentialKGO2023-08-23 View
510(k) K213289 Gammex® PI Plus Glove-in-Glove™ System Tested For Use with Chemotherapy DrugsKGO2023-05-26 View
510(k) K212148 Non-Sterile Powder-Free Polychloroprene Examination Glove (Blue) Tested for Use with Chemotherapy DrugsLZA2022-03-10 View
510(k) K210401 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 Nitrile Patient Examination Gloves Black Colored Tested for Use with Chemotherapy Drugs and Fentanyl CitrateLZA2021-06-13 View
510(k) K200671 Microflex Nitrile Patient Examination Gloves with Aloe and Chamomile Blue Green Pink Colored Tested forLZA2020-06-19 View
510(k) K190018 Gammex Non Latex PI White Polyisoprene Surgical Gloves Tested for Use with Chemotherapy DrugsKGO2019-05-23 View
510(k) K182948 Gammex PI Hybrid Surgical Gloves Tested for Use with Chemotherapy DrugsKGO2019-03-22 View
510(k) K171375 Gammex PI Breach Detect Powder Free Surgical GloveKGO2018-02-06 View
510(k) K171737 Micro Touch Denta Glove Nitrile Hydrasoft Patient Examination GlovesLZA2017-12-29 View
510(k) K171172 Skyn Original Polyisoprene Lubricated Male Condom - FlavoredMOL2017-08-02 View
510(k) K163107 Lifestyles Zero Lubricated Latex Male CondomHIS2017-01-23 View
510(k) K160974 Gammex Cut-Resistant Glove LinerKGO2016-10-28 View
510(k) K160399 Skyn Original Polyisoprene Lubricated Male CondomMOL2016-07-25 View
510(k) K151694 Gammex PI Hybrid Surgical GlovesKGO2016-03-09 View
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