FDA 510(k) Applications Submitted by Don Cronk

FDA 510(k) Number Submission Date Device Name Applicant
K190018 01/04/2019 Gammex Non Latex PI White Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs Ansell Healthcare Products, LLC.
K230079 01/10/2023 Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs and Low Dermatitis Potential Ansell Healthcare Products, LLC.
K182948 10/23/2018 Gammex PI Hybrid Surgical Gloves Tested for Use with Chemotherapy Drugs 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


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