Ansell Healthcare Products, LLC
Ansell Healthcare Products, LLC holds FDA 510(k) medical device clearances, first cleared 2005, most recent 2023, with 7 FDA device recalls on record.
Top product codes for Ansell Healthcare Products, LLC
FDA recalls by Ansell Healthcare Products, LLC
- Z-0097-2024 — NOVAPLUS GAMMEX NON-LATEX PI GREEN Surgical gloves, REF: V20685255 through V20685290
- Z-0096-2024 — GAMMEX NON-LATEX PI GREEN Surgical gloves, REF: 20685255 through 20685290
- Z-0838-2022 — Gammex Non-Latex PI Green PI-KARE Skin-friendly PI Technology polyisoprene surgical gloves 7 1/2
- Z-0051-2021 — MICROFLEX Diamond Grip Examination Gloves, MF-300 - Product Usage: A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner s hand or finger to prevent contamination between patient and examiner.
- Z-0893-2017 — Gammex Non-Latex Sensitive Neoprene Surgical Gloves Ansell Lanka (pvt) Ltd. Biyagama Export Processing Zone, Biyagama, Sri Lanka Ansell Healthcare Europe, N.V Internationaleiaan 55, 1070 Brussels, Belgium Manufactured for/ Fabrique' pour: Ansell Healthcare products LLC. 1635 Industrial Road Dothan, AL 36303, USA TEL USA- 1-800-952-9916 CAN- 1-844-494-7854 catalog #20277285
- Z-0838-2013 — LifeStyles ZERO 10 uber-thin lubricated latex condoms. Mfd. for Ansell Healthcare Products LLC, Dothan, AL 96303. A sheath which completely covers the penis with a closely fitting membrane. The condom is used for contraceptive and for prophylactic purposes (preventing transmission of sexually transmitted infections).
- Z-0717-2013 — Lifestyles Pleasure Collection 30 Premium Lubricated Condoms Assortment of Ultra Sensitive, Flavors and Colors, Skyn, Thryll, Thyn, and Ultra Thin. UPC 0-70907-02625-0.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Ansell Healthcare Products, LLC
- K230079 — Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs and Low Dermatitis Potential
- K213289 — Gammex® PI Plus Glove-in-Glove System Tested For Use with Chemotherapy Drugs
- K212148 — Non-Sterile Powder-Free Polychloroprene Examination Glove (Blue) Tested for Use with Chemotherapy Drugs
- K210401 — 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 Nitrile Patient Examination Gloves Black Colored Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
- K200671 — Microflex Nitrile Patient Examination Gloves with Aloe and Chamomile Blue Green Pink Colored Tested for
- K190018 — Gammex Non Latex PI White Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs
- K182948 — Gammex PI Hybrid Surgical Gloves Tested for Use with Chemotherapy Drugs
- K171375 — Gammex PI Breach Detect Powder Free Surgical Glove
- K171737 — Micro Touch Denta Glove Nitrile Hydrasoft Patient Examination Gloves
- K171172 — Skyn Original Polyisoprene Lubricated Male Condom - Flavored
- K163107 — Lifestyles Zero Lubricated Latex Male Condom
- K160974 — Gammex Cut-Resistant Glove Liner
- K160399 — Skyn Original Polyisoprene Lubricated Male Condom
- K151694 — Gammex PI Hybrid Surgical Gloves
- K122476 — LIFESTYLES SMOOTH 2-IN-1 MASSAGE & LUBRICANT
- K122720 — LIFESTYLES WARM LOVIN PERSONAL LUBRICANT
- K122477 — LIFESTYLES LUXE PREMIUM PERSONAL LUBRICANT
- K122054 — LIFESTYLES NATURAL PERSONAL LUBRICANT
- K103714 — ENCORE ACCLAIM STERILE POWDER-FREE LATEX SURGICAL GLOVES, TESTED FOR USE WITH CHEMOTHERA
- K093523 — MICRO-TOUCH NITRILE
- K092327 — MICRO-TOUCH NITRA FREE
- K080536 — MICRO-TOUCH NITRAFREE
- K070800 — LIFESTYLES LUBRICATED POLYISOPRENE LATEX MALE CONDOM
- K071746 — DERMA PRENE PI OR ISOTOUCH GREEN STERILE POWDER-FREE SYNTHETIC POLYISOPRENE SURGICAL GLOVES
- K051793 — ENCORE STERILE POWDER-FREE LATEX SURGICAL GLOVE WITH PROPRIETARY COATING (CONTAINING GLYCERINE)
- K043508 — DERMA PRENE ULTRA POWDER-FREE POLYCHLOROPRENE SYNTHETIC SURGICAL GLOVES (CHEMOTHERAPY USE)
Data sourced from openFDA. This site is unofficial and independent of the FDA.