Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Ansell Healthcare Products, LLC

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

Total Devices14
Categories4
Latest Approval2023-08-23
TypeNumberDevice NameCodeDate
510(k) K230079 Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs and Low Dermatitis Potential KGO 2023-08-23 View
510(k) K213289 Gammex® PI Plus Glove-in-Glove™ System Tested For Use with Chemotherapy Drugs KGO 2023-05-26 View
510(k) K212148 Non-Sterile Powder-Free Polychloroprene Examination Glove (Blue) Tested for Use with Chemotherapy Drugs LZA 2022-03-10 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 Citrate LZA 2021-06-13 View
510(k) K200671 Microflex Nitrile Patient Examination Gloves with Aloe and Chamomile Blue Green Pink Colored Tested for LZA 2020-06-19 View
510(k) K190018 Gammex Non Latex PI White Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs KGO 2019-05-23 View
510(k) K182948 Gammex PI Hybrid Surgical Gloves Tested for Use with Chemotherapy Drugs KGO 2019-03-22 View
510(k) K171375 Gammex PI Breach Detect Powder Free Surgical Glove KGO 2018-02-06 View
510(k) K171737 Micro Touch Denta Glove Nitrile Hydrasoft Patient Examination Gloves LZA 2017-12-29 View
510(k) K171172 Skyn Original Polyisoprene Lubricated Male Condom - Flavored MOL 2017-08-02 View
510(k) K163107 Lifestyles Zero Lubricated Latex Male Condom HIS 2017-01-23 View
510(k) K160974 Gammex Cut-Resistant Glove Liner KGO 2016-10-28 View
510(k) K160399 Skyn Original Polyisoprene Lubricated Male Condom MOL 2016-07-25 View
510(k) K151694 Gammex PI Hybrid Surgical Gloves KGO 2016-03-09 View