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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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