Ansell Healthcare Products, LLC is one of 12946 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Ansell Healthcare Products, LLC - FDA 510(k) Cleared Devices
Recent clearances: Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs and Low Dermatitis Potential, Gammex® PI Plus Glove-in-Glove™ System Tested For Use with Chemotherapy Drugs, Non-Sterile Powder-Free Polychloroprene Examination Glove (Blue) Tested for Use with Chemotherapy Drugs
26
Total
26
Cleared
0
Denied
Ansell Healthcare Products, LLC has 26 FDA 510(k) cleared medical devices. Based in Dothan, US.
Last cleared in 2023. Active since 2005. Primary specialty: General Hospital.
Browse the FDA 510(k) cleared devices submitted by Ansell Healthcare Products, LLC Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Underwriters Laboratories, Inc. as regulatory consultant.
FDA 510(k) Regulatory Record - Ansell Healthcare Products, LLC
26 devices
Cleared
Aug 23, 2023
Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs and Low...
General Hospital
225d
Cleared
May 26, 2023
Gammex® PI Plus Glove-in-Glove™ System Tested For Use with Chemotherapy Drugs
General Hospital
602d
Cleared
Mar 10, 2022
Non-Sterile Powder-Free Polychloroprene Examination Glove (Blue) Tested for...
General Hospital
244d
Cleared
Jun 13, 2021
Microflex Nitrile Patient Examination Gloves Blue Colored Tested for Use with...
General Hospital
123d
Cleared
Jun 19, 2020
Microflex Nitrile Patient Examination Gloves with Aloe and Chamomile Blue...
General Hospital
98d
Cleared
May 23, 2019
Gammex Non Latex PI White Polyisoprene Surgical Gloves Tested for Use with...
General Hospital
139d
Cleared
Mar 22, 2019
Gammex PI Hybrid Surgical Gloves Tested for Use with Chemotherapy Drugs
General Hospital
150d
Cleared
Feb 06, 2018
Gammex PI Breach Detect Powder Free Surgical Glove
General Hospital
272d
Cleared
Dec 29, 2017
Micro Touch Denta Glove Nitrile Hydrasoft Patient Examination Gloves
General Hospital
200d
Cleared
Aug 02, 2017
Skyn Original Polyisoprene Lubricated Male Condom - Flavored
Obstetrics & Gynecology
103d
Cleared
Jan 23, 2017
Lifestyles Zero Lubricated Latex Male Condom
Obstetrics & Gynecology
77d
Cleared
Oct 28, 2016
Gammex Cut-Resistant Glove Liner
General Hospital
204d