FDA 510(k) Applications Submitted by Ansell Healthcare Products, LLC
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K071746 |
06/27/2007 |
DERMA PRENE PI OR ISOTOUCH GREEN STERILE POWDER-FREE SYNTHETIC POLYISOPRENE SURGICAL GLOVES |
ANSELL HEALTHCARE PRODUCTS, LLC |
| K051793 |
07/01/2005 |
ENCORE STERILE POWDER-FREE LATEX SURGICAL GLOVE WITH PROPRIETARY COATING (CONTAINING GLYCERINE) |
ANSELL HEALTHCARE PRODUCTS, LLC |
| K122476 |
08/14/2012 |
LIFESTYLES SMOOTH 2-IN-1 MASSAGE & LUBRICANT |
ANSELL HEALTHCARE PRODUCTS, LLC |
| K122054 |
07/13/2012 |
LIFESTYLES NATURAL PERSONAL LUBRICANT |
ANSELL HEALTHCARE PRODUCTS, LLC |
| K103714 |
12/21/2010 |
ENCORE ACCLAIM STERILE POWDER-FREE LATEX SURGICAL GLOVES, TESTED FOR USE WITH CHEMOTHERA |
ANSELL HEALTHCARE PRODUCTS, LLC |
| K160399 |
02/12/2016 |
Skyn Original Polyisoprene Lubricated Male Condom |
Ansell Healthcare Products, LLC |
| K163107 |
11/07/2016 |
Lifestyles Zero Lubricated Latex Male Condom |
ANSELL HEALTHCARE PRODUCTS, LLC |
| K213289 |
10/01/2021 |
Gammex« PI Plus Glove-in-GloveÖ System Tested For Use with Chemotherapy Drugs |
Ansell Healthcare Products, LLC |
| K151694 |
06/23/2015 |
Gammex PI Hybrid Surgical Gloves |
ANSELL HEALTHCARE PRODUCTS, LLC |
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