Ansell Healthcare Products LLC
FDA Regulatory Profile
Summary
- Total Recalls
- 7
- 510(k) Clearances
- 36
- Inspections
- 2
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0097-2024 | Class II | NOVAPLUS GAMMEX NON-LATEX PI GREEN Surgical gloves, REF: V20685255 through V20685290 | August 3, 2023 |
| Z-0096-2024 | Class II | GAMMEX NON-LATEX PI GREEN Surgical gloves, REF: 20685255 through 20685290 | August 3, 2023 |
| Z-0838-2022 | Class II | Gammex Non-Latex PI Green PI-KARE Skin-friendly PI Technology polyisoprene surgical gloves 7 1/2 | February 19, 2022 |
| Z-0051-2021 | Class II | MICROFLEX Diamond Grip Examination Gloves, MF-300 - Product Usage: A patient examination glove is a | August 19, 2020 |
| Z-0893-2017 | Class II | Gammex Non-Latex Sensitive Neoprene Surgical Gloves Ansell Lanka (pvt) Ltd. Biyagama Export Proce | October 24, 2016 |
| Z-0838-2013 | Class II | LifeStyles ZERO 10 uber-thin lubricated latex condoms. Mfd. for Ansell Healthcare Products LLC, Dot | January 14, 2013 |
| Z-0717-2013 | Class II | Lifestyles Pleasure Collection 30 Premium Lubricated Condoms Assortment of Ultra Sensitive, Flavo | November 5, 2012 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K230079 | Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs and Low Dermatitis Potential | August 23, 2023 |
| K213289 | Gammex® PI Plus Glove-in-Glove System Tested For Use with Chemotherapy Drugs | May 26, 2023 |
| K212148 | Non-Sterile Powder-Free Polychloroprene Examination Glove (Blue) Tested for Use with Chemotherapy Dr | March 10, 2022 |
| K210401 | Microflex Nitrile Patient Examination Gloves Blue Colored Tested for Use with Chemotherapy Drugs and | June 13, 2021 |
| K200671 | Microflex Nitrile Patient Examination Gloves with Aloe and Chamomile Blue Green Pink Colored Tested | June 19, 2020 |
| K190018 | Gammex Non Latex PI White Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs | May 23, 2019 |
| K182948 | Gammex PI Hybrid Surgical Gloves Tested for Use with Chemotherapy Drugs | March 22, 2019 |
| K171375 | Gammex PI Breach Detect Powder Free Surgical Glove | February 6, 2018 |
| K171737 | Micro Touch Denta Glove Nitrile Hydrasoft Patient Examination Gloves | December 29, 2017 |
| K171172 | Skyn Original Polyisoprene Lubricated Male Condom - Flavored | August 2, 2017 |
| K163107 | Lifestyles Zero Lubricated Latex Male Condom | January 23, 2017 |
| K160974 | Gammex Cut-Resistant Glove Liner | October 28, 2016 |
| K160399 | Skyn Original Polyisoprene Lubricated Male Condom | July 25, 2016 |
| K151694 | Gammex PI Hybrid Surgical Gloves | March 9, 2016 |
| K122476 | LIFESTYLES SMOOTH 2-IN-1 MASSAGE & LUBRICANT | March 7, 2013 |
| K122720 | LIFESTYLES WARM LOVIN PERSONAL LUBRICANT | February 22, 2013 |
| K122477 | LIFESTYLES LUXE PREMIUM PERSONAL LUBRICANT | February 19, 2013 |
| K122054 | LIFESTYLES NATURAL PERSONAL LUBRICANT | February 14, 2013 |
| K111139 | DERMA PRENE ISOTOUCH GREEN STERILE POWDER-FREE POLYISOPRENE SURGICAL GOVES, TESTED FOR U | September 2, 2011 |
| K103714 | ENCORE ACCLAIM STERILE POWDER-FREE LATEX SURGICAL GLOVES, TESTED FOR USE WITH CHEMOTHERA | July 7, 2011 |