Ansell Healthcare Products LLC
Iselin, NJ, US
ANSELL HEALTHCARE PRODUCTS LLC appears in FDA device records in Iselin, NJ. FDA records list 39 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show 29 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Ansell Healthcare Products LLC carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Ansell Healthcare, Inc.510(k), recall
510(k) clearance history
FDA records hold 39 510(k) clearances for Ansell Healthcare Products LLC between 2000 and 2023. The busiest year on record is 2001, with 5. The most recent is 2023, with 3.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2000 | 2 |
| 2001 | 5 |
| 2002 | 1 |
| 2003 | 1 |
| 2004 | 1 |
| 2005 | 2 |
| 2007 | 1 |
| 2008 | 3 |
| 2009 | 1 |
| 2010 | 1 |
| 2011 | 2 |
| 2013 | 4 |
| 2016 | 3 |
| 2017 | 3 |
| 2018 | 1 |
| 2019 | 2 |
| 2020 | 1 |
| 2021 | 1 |
| 2022 | 1 |
| 2023 | 3 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K231902 | GAMMEX PI Hybrid Micro (340002055); GAMMEX PI Hybrid Micro (340002060); GAMMEX PI Hybrid Micro (340002065); GAMMEX PI Hybrid Micro (340002070); GAMMEX PI Hybrid Micro (340002075); GAMMEX PI Hybrid Micro (340002080); GAMMEX PI Hybrid Micro (340002085); GAMMEX PI Hybrid Micro (340002090) | KGO | Substantially Equivalent | |
| K230079 | Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs and Low Dermatitis Potential | KGO | Substantially Equivalent | |
| K213289 | Gammex® PI Plus Glove-in-Glove™ System Tested For Use with Chemotherapy Drugs | KGO | Substantially Equivalent | |
| K212148 | Non-Sterile Powder-Free Polychloroprene Examination Glove (Blue) Tested for Use with Chemotherapy Drugs | LZA | Substantially Equivalent | |
| 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 | LZA | Substantially Equivalent | |
| K200671 | Microflex Nitrile Patient Examination Gloves with Aloe and Chamomile Blue Green Pink Colored Tested for | LZA | Substantially Equivalent | |
| K190018 | Gammex Non Latex PI White Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs | KGO | Substantially Equivalent | |
| K182948 | Gammex PI Hybrid Surgical Gloves Tested for Use with Chemotherapy Drugs | KGO | Substantially Equivalent | |
| K171375 | Gammex PI Breach Detect Powder Free Surgical Glove | KGO | Substantially Equivalent | |
| K171737 | Micro Touch Denta Glove Nitrile Hydrasoft Patient Examination Gloves | LZA | Substantially Equivalent | |
| K171172 | Skyn Original Polyisoprene Lubricated Male Condom - Flavored | MOL | Substantially Equivalent | |
| K163107 | Lifestyles Zero Lubricated Latex Male Condom | HIS | Substantially Equivalent | |
| K160974 | Gammex Cut-Resistant Glove Liner | KGO | Substantially Equivalent | |
| K160399 | Skyn Original Polyisoprene Lubricated Male Condom | MOL | Substantially Equivalent | |
| K151694 | Gammex PI Hybrid Surgical Gloves | KGO | Substantially Equivalent | |
| K122476 | LIFESTYLES SMOOTH 2-IN-1 MASSAGE & LUBRICANT | NUC | Substantially Equivalent | |
| K122720 | LIFESTYLES WARM LOVIN PERSONAL LUBRICANT | NUC | Substantially Equivalent | |
| K122477 | LIFESTYLES LUXE PREMIUM PERSONAL LUBRICANT | NUC | Substantially Equivalent | |
| K122054 | LIFESTYLES NATURAL PERSONAL LUBRICANT | NUC | Substantially Equivalent | |
| K111139 | DERMA PRENE ISOTOUCH GREEN STERILE POWDER-FREE POLYISOPRENE SURGICAL GOVES, TESTED FOR U | KGO | Substantially Equivalent | |
| K103714 | ENCORE ACCLAIM STERILE POWDER-FREE LATEX SURGICAL GLOVES, TESTED FOR USE WITH CHEMOTHERA | KGO | Substantially Equivalent | |
| K093523 | MICRO-TOUCH NITRILE | LZA | Substantially Equivalent | |
| K092327 | MICRO-TOUCH NITRA FREE | LZA | Substantially Equivalent | |
| K082457 | MICRO-TOUCH NITRATEX STERILE NITRILE POWDER-FREE BLUE EXAMINATION GLOVES (CHEMOTHERAPY USE) | LZA | Substantially Equivalent | |
| K080536 | MICRO-TOUCH NITRAFREE | LZA | Substantially Equivalent | |
| K070800 | LIFESTYLES LUBRICATED POLYISOPRENE LATEX MALE CONDOM | MOL | Substantially Equivalent | |
| K071746 | DERMA PRENE PI OR ISOTOUCH GREEN STERILE POWDER-FREE SYNTHETIC POLYISOPRENE SURGICAL GLOVES | KGO | Substantially Equivalent | |
| K051793 | ENCORE STERILE POWDER-FREE LATEX SURGICAL GLOVE WITH PROPRIETARY COATING (CONTAINING GLYCERINE) | KGO | Substantially Equivalent | |
| K043508 | DERMA PRENE ULTRA POWDER-FREE POLYCHLOROPRENE SYNTHETIC SURGICAL GLOVES (CHEMOTHERAPY USE) | KGO | Substantially Equivalent | |
| K042817 | MICRO-TOUCH SMOOTH NITRILE POWDER-FREE BLUE EXAMINATION GLOVES (CHEMOTHERAPY USE) | LZA | Substantially Equivalent | |
| K033076 | LIFESTYLES LIQUID PERSONAL LUBRICANT | HIS | Substantially Equivalent | |
| K023153 | MICRO-TOUCH NEXT STEP POWDER FREE MEDICAL EXAMINATION GLOVES WITH ALOE AND GLYCEROL | LYY | Substantially Equivalent | |
| K013604 | MODIFICATION TO: ULTRALON (R) POWDER FREE LATEX SURGICAL GLOVES | KGO | Substantially Equivalent | |
| K013603 | MODIFICATION TO:MICRO TOUCH (R) POWDER FREE LATEX SURGICAL GLOVES , MODEL STYLE 65 | KGO | Substantially Equivalent | |
| K011593 | MICRO-TOUCH NITRILE POWDER FREE SYNTHETIC MEDICAL EXAMINATION GLOVES, COLOR BLUE NON-STERILE | LZA | Substantially Equivalent | |
| K010961 | X-TENDA CUFF POWDER FREE NON-STERILE LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) | LYY | Substantially Equivalent | |
| K003771 | ENCORE POWDER-FREE LATEX SURGICAL GLOVES, ORTHOPAEDIC WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) | KGO | Substantially Equivalent | |
| K003769 | ENCORE MICROPTIC POWDER FREE LATEX SURGICAL GLOVES, MODEL 87 | KGO | Substantially Equivalent | |
| K001883 | LIFESTYLES, CONTEMPO OR PRIVATE LABEL LARGE CONDOM | HIS | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3009964047 | 3009964047 | ANSELL HEALTHCARE PRODUCTS LLC | 111 Wood Ave S Suite 210, Iselin, NJ 08830 US | 2026 | |
| 3011209798 | 3011209798 | ANSELL HEALTHCARE PRODUCTS LLC | 2301 Robb Drive, Reno, NV 89523 US | 2026 | and 6 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- LYUAccessory, Surgical Apparel
- NNWBag, Urine Collection, Leg, For External Use, Non-Sterile
- KMEBedding, Disposable, Medical
- HISCondom
- MOLCondom, Synthetic
- QDOFentanyl And Other Opioid Protection Glove
- LYYLatex Patient Examination Glove
- NUCLubricant, Personal
- FZZMarker, Skin
- LZCMedical Glove, Specialty
- OPJMedical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs
- OEANon-Surgical Gown
- LZAPolymer Patient Examination Glove
- IWPRadiographic Protective Glove
- MSHRespirator, Surgical
- CCXSupport, Patient Position
- KGOSurgeon'S Gloves
- GAXTourniquet, Nonpneumatic
- LYZVinyl Patient Examination Glove
Recall records
Showing 25 of 29| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0097-2024 | NOVAPLUS GAMMEX NON-LATEX PI GREEN Surgical gloves, REF: V20685255 through V20685290 | Some surgical glove sterile pouches were not completely sealed. | Class II | Open, Classified | |
| Z-0096-2024 | GAMMEX NON-LATEX PI GREEN Surgical gloves, REF: 20685255 through 20685290 | Some surgical glove sterile pouches were not completely sealed. | Class II | Open, Classified | |
| Z-0838-2022 | Gammex Non-Latex PI Green PI-KARE Skin-friendly PI Technology polyisoprene surgical gloves 7 1/2 | Transport company failed to stop at the border for required FDA inspection. | Class II | Open, Classified | |
| 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. | Examination gloves were shipped inadvertently, without to verify barrier integrity. | Class II | Terminated | |
| 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 | Ansell Healthcare Products is initiating a voluntary recall involving 15 cases of Gammex Non Latex Sensitive Surgical Gloves because the packaged contents incorrectly included a natural rubber Latex surgical glove. | Class II | Terminated | |
| 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). | Out of an abundance of caution, Ansell is implementing a voluntary recall of the Zero Latex Condom (regular) product. The condom has met or exceeded test and quality standards required by the Food and Drug Administration. However, we are experiencing a number of complaints concerning the difficulty in unrolling and subsequent breakage, and so we are asking to have all products returned. | Class II | Terminated | |
| 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. | One lot of Lifestyles Pleasure Collection Lubricated Condoms is misbranded. Ultra Thin was included rather than Skyn. | Class II | Terminated | |
| Z-3117-2011 | MICRO-TOUCH(R), XL (indicating size extra large), NITRILE, Powder Free, Medical Examination Gloves, REF 6034304, 200 Pieces, Manufactured for: Ansell Healthcare - Made in Malaysia | Gloves were inadvertently released for distribution prior to completion of testing required by the U.S. Food and Drug Administration. | Terminated | ||
| Z-3116-2011 | MICRO-TOUCH(R), L (indicating size large), NITRILE, Powder Free, Medical Examination Gloves, REF 6034303, 200 Pieces, Manufactured for: Ansell Healthcare - Made in Malaysia | Gloves were inadvertently released for distribution prior to completion of testing required by the U.S. Food and Drug Administration. | Terminated | ||
| Z-3115-2011 | MICRO-TOUCH(R), M (indicating size medium), NITRILE, Powder Free, Medical Examination Gloves, REF 6034302, 200 Pieces, Manufactured for: Ansell Healthcare - Made in Malaysia | Gloves were inadvertently released for distribution prior to completion of testing required by the U.S. Food and Drug Administration. | Terminated | ||
| Z-3114-2011 | MICRO-TOUCH(R), S (indicating size small), NITRILE, Powder Free, Medical Examination Gloves, REF 6034301, 200 Pieces, Manufactured for: Ansell Healthcare - Made in Malaysia | Gloves were inadvertently released for distribution prior to completion of testing required by the U.S. Food and Drug Administration. | Terminated | ||
| Z-2847-2011 | ENCORE(R) UNDERGLOVE, Latex, Powder-Free, Smooth Surgical Gloves, REF 2018490, Size 9, Sterile, Manufactured for Ansell Healthcare, 1635 Industrial Road, Dothan, AL 36303, Made in Sri Lanka Surgical gloves | Gloves do not meet the tensile requirements of ASTM D 3577 reducing the shelf life of the product from 5 years to 2 years. | Terminated | ||
| Z-2846-2011 | ENCORE(R) UNDERGLOVE, Latex, Powder-Free, Smooth Surgical Gloves, REF 2018485, Size 8 1/2, Sterile, Manufactured for Ansell Healthcare, 1635 Industrial Road, Dothan, AL 36303, Made in Sri Lanka Surgical gloves | Gloves do not meet the tensile requirements of ASTM D 3577 reducing the shelf life of the product from 5 years to 2 years. | Terminated | ||
| Z-2845-2011 | ENCORE(R) UNDERGLOVE, Latex, Powder-Free, Smooth Surgical Gloves, REF 2018480, Size 8, Sterile, Manufactured for Ansell Healthcare, 1635 Industrial Road, Dothan, AL 36303, Made in Sri Lanka Surgical gloves | Gloves do not meet the tensile requirements of ASTM D 3577 reducing the shelf life of the product from 5 years to 2 years. | Terminated | ||
| Z-2844-2011 | ENCORE(R) UNDERGLOVE, Latex, Powder-Free, Smooth Surgical Gloves, REF 2018475, Size 7 1/2, Sterile, Manufactured for Ansell Healthcare, 1635 Industrial Road, Dothan, AL 36303, Made in Sri Lanka Surgical gloves | Gloves do not meet the tensile requirements of ASTM D 3577 reducing the shelf life of the product from 5 years to 2 years. | Terminated | ||
| Z-2843-2011 | ENCORE(R) UNDERGLOVE, Latex, Powder-Free, Smooth Surgical Gloves, REF 2018470, Size 7, Sterile, Manufactured for Ansell Healthcare, 1635 Industrial Road, Dothan, AL 36303, Made in Sri Lanka Surgical gloves | Gloves do not meet the tensile requirements of ASTM D 3577 reducing the shelf life of the product from 5 years to 2 years. | Terminated | ||
| Z-2842-2011 | ENCORE(R) UNDERGLOVE, Latex, Powder-Free, Smooth Surgical Gloves, REF 2018465, Size 6 1/2, Sterile, Manufactured for Ansell Healthcare, 1635 Industrial Road, Dothan, AL 36303, Made in Sri Lanka Surgical gloves | Gloves do not meet the tensile requirements of ASTM D 3577 reducing the shelf life of the product from 5 years to 2 years. | Terminated | ||
| Z-2841-2011 | ENCORE(R) UNDERGLOVE, Latex, Powder-Free, Smooth Surgical Gloves, REF 2018460, Size 6, Sterile, Manufactured for Ansell Healthcare, 1635 Industrial Road, Dothan, AL 36303, Made in Sri Lanka Surgical gloves | Gloves do not meet the tensile requirements of ASTM D 3577 reducing the shelf life of the product from 5 years to 2 years. | Terminated | ||
| Z-2840-2011 | ENCORE(R) UNDERGLOVE, Latex, Powder-Free, Smooth Surgical Gloves, REF 2018455, Size 5 1/2, Sterile, Manufactured for Ansell Healthcare, 1635 Industrial Road, Dothan, AL 36303, Made in Sri Lanka Surgical gloves | Gloves do not meet the tensile requirements of ASTM D 3577 reducing the shelf life of the product from 5 years to 2 years. | Terminated | ||
| Z-0621-2011 | ENCORE (R) Microptic (R) Powder-Free Latex Surgical Gloves, 1 Pair, Size 5, Sterile R, CE 0086, EC REP Ansell (UK) Ltd., Tamworth, Staffordshire, B79 7UL UK, Ansell Lanka (pvt) Ltd., Biyagama Export Processing Zone, Biyagama, Sri Lanka Intended use: Surgical Gloves | open package seams on sterile gloves | Terminated | ||
| Z-1589-2009 | Ansell, Derma Prene Ultra, Powder-Free, Smooth Surgical Gloves, REF 8518, Size 9, 4 boxes of 50, Sterile, Distributed by Ansell Healthcare, 1635 Industrial Road, Dothan, AL, 36303, USA, Made in Sri Lanka. The device is made of synthetic rubber and is intended to be worn by operating room personnel to protect a surgical wound from contamination and for use in handling chemotherapy drugs. | Premature degradation which could result in tearing during use. | Terminated | ||
| Z-1588-2009 | Ansell, Derma Prene Ultra, Powder-Free, Smooth Surgical Gloves, REF 8517, Size 8 1/2, 4 boxes of 50, Sterile, Distributed by Ansell Healthcare, 1635 Industrial Road, Dothan, AL, 36303, USA, Made in Sri Lanka. The device is made of synthetic rubber and is intended to be worn by operating room personnel to protect a surgical wound from contamination and for use in handling chemotherapy drugs. | Premature degradation which could result in tearing during use. | Terminated | ||
| Z-1587-2009 | Ansell, Derma Prene Ultra, Powder-Free, Smooth Surgical Gloves, REF 8516, Size 8, 4 boxes of 50, Sterile, Distributed by Ansell Healthcare, 1635 Industrial Road, Dothan, AL, 36303, USA, Made in Sri Lanka. The device is made of synthetic rubber and is intended to be worn by operating room personnel to protect a surgical wound from contamination and for use in handling chemotherapy drugs. | Premature degradation which could result in tearing during use. | Terminated | ||
| Z-1586-2009 | Ansell, Derma Prene Ultra, Powder-Free, Smooth Surgical Gloves, REF 8515, Size 7 1/2, 4 boxes of 50, Sterile, Distributed by Ansell Healthcare, 1635 Industrial Road, Dothan, AL, 36303, USA, Made in Sri Lanka. The device is made of synthetic rubber and is intended to be worn by operating room personnel to protect a surgical wound from contamination and for use in handling chemotherapy drugs. | Premature degradation which could result in tearing during use. | Terminated | ||
| Z-1585-2009 | Ansell, Derma Prene Ultra, Powder-Free, Smooth Surgical Gloves, REF 8514, Size 7, 4 boxes of 50, Sterile, Distributed by Ansell Healthcare, 1635 Industrial Road, Dothan, AL, 36303, USA, Made in Sri Lanka. The device is made of synthetic rubber and is intended to be worn by operating room personnel to protect a surgical wound from contamination and for use in handling chemotherapy drugs. | Premature degradation which could result in tearing during use. | Terminated |
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets Ansell Healthcare Products LLC edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
Data as of , FDA export datePage updated Source: openFDA, public domain