Medical Device Manufacturer · US , Dothan , AL

Ansell Healthcare Products, LLC - FDA 510(k) Cleared Devices

26 submissions · 26 cleared · Since 2005

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

FDA 510(k) Regulatory Record - Ansell Healthcare Products, LLC Obstetrics & Gynecology ✕

8 devices

1-8 of 8

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 Jul 25, 2016

Skyn Original Polyisoprene Lubricated Male Condom

Obstetrics & Gynecology · 164d

Cleared Mar 07, 2013

LIFESTYLES SMOOTH 2-IN-1 MASSAGE & LUBRICANT

Obstetrics & Gynecology · 205d

Cleared Feb 22, 2013

LIFESTYLES WARM LOVIN PERSONAL LUBRICANT

Obstetrics & Gynecology · 170d

Cleared Feb 19, 2013

LIFESTYLES LUXE PREMIUM PERSONAL LUBRICANT

Obstetrics & Gynecology · 189d

Cleared Feb 14, 2013

LIFESTYLES NATURAL PERSONAL LUBRICANT

Obstetrics & Gynecology · 216d

Cleared Mar 06, 2008

LIFESTYLES LUBRICATED POLYISOPRENE LATEX MALE CONDOM

Obstetrics & Gynecology · 349d