Company · US
Ansell Healthcare Products LLC
FDA 510(k) clearances and medical device recalls filed under this name, 2000 to 2023. Name variants (Inc, Corp, punctuation) are merged.
36510(k) clearances (0 in 12 months)
27recalls (0 in 12 months)
27recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 23, 2023 | K230079 | Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs and Low Dermatitis Potential Ansell Healthcare Products, LLC | KGO |
| May 26, 2023 | K213289 | Gammex® PI Plus Glove-in-Glove System Tested For Use with Chemotherapy Drugs Ansell Healthcare Products, LLC | KGO |
| Mar 10, 2022 | K212148 | Non-Sterile Powder-Free Polychloroprene Examination Glove (Blue) Tested for Use with Chemotherapy Drugs Ansell Healthcare Products, LLC | LZA |
| Jun 13, 2021 | K210401 | Microflex Nitrile Patient Examination Gloves Blue Colored Tested for Use with Chemotherapy Drugs and Fentanyl Citrate, M Ansell Healthcare Products, LLC | LZA |
| Jun 19, 2020 | K200671 | Microflex Nitrile Patient Examination Gloves with Aloe and Chamomile Blue Green Pink Colored Tested for Ansell Healthcare Products, LLC | LZA |
| May 23, 2019 | K190018 | Gammex Non Latex PI White Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs Ansell Healthcare Products, LLC | KGO |
| Mar 22, 2019 | K182948 | Gammex PI Hybrid Surgical Gloves Tested for Use with Chemotherapy Drugs Ansell Healthcare Products, LLC | KGO |
| Feb 6, 2018 | K171375 | Gammex PI Breach Detect Powder Free Surgical Glove Ansell Healthcare Products, LLC | KGO |
| Dec 29, 2017 | K171737 | Micro Touch Denta Glove Nitrile Hydrasoft Patient Examination Gloves Ansell Healthcare Products, LLC | LZA |
| Aug 2, 2017 | K171172 | Skyn Original Polyisoprene Lubricated Male Condom - Flavored Ansell Healthcare Products, LLC | MOL |
| Jan 23, 2017 | K163107 | Lifestyles Zero Lubricated Latex Male Condom Ansell Healthcare Products, LLC | HIS |
| Oct 28, 2016 | K160974 | Gammex Cut-Resistant Glove Liner Ansell Healthcare Products, LLC | KGO |
| Jul 25, 2016 | K160399 | Skyn Original Polyisoprene Lubricated Male Condom Ansell Healthcare Products, LLC | MOL |
| Mar 9, 2016 | K151694 | Gammex PI Hybrid Surgical Gloves Ansell Healthcare Products, LLC | KGO |
| Mar 7, 2013 | K122476 | LIFESTYLES SMOOTH 2-IN-1 MASSAGE & LUBRICANT Ansell Healthcare Products, LLC | NUC |
| Feb 22, 2013 | K122720 | LIFESTYLES WARM LOVIN PERSONAL LUBRICANT Ansell Healthcare Products, LLC | NUC |
| Feb 19, 2013 | K122477 | LIFESTYLES LUXE PREMIUM PERSONAL LUBRICANT Ansell Healthcare Products, LLC | NUC |
| Feb 14, 2013 | K122054 | LIFESTYLES NATURAL PERSONAL LUBRICANT Ansell Healthcare Products, LLC | NUC |
| Sep 2, 2011 | K111139 | DERMA PRENE ISOTOUCH GREEN STERILE POWDER-FREE POLYISOPRENE SURGICAL GOVES, TESTED FOR U Ansell Healthcare Products, Inc. | KGO |
| Jul 7, 2011 | K103714 | ENCORE ACCLAIM STERILE POWDER-FREE LATEX SURGICAL GLOVES, TESTED FOR USE WITH CHEMOTHERA Ansell Healthcare Products, LLC | KGO |
| Mar 4, 2010 | K093523 | MICRO-TOUCH NITRILE Ansell Healthcare Products, LLC | LZA |
| Sep 21, 2009 | K092327 | MICRO-TOUCH NITRA FREE Ansell Healthcare Products, LLC | LZA |
| Nov 10, 2008 | K082457 | MICRO-TOUCH NITRATEX STERILE NITRILE POWDER-FREE BLUE EXAMINATION GLOVES (CHEMOTHERAPY USE) Ansell Healthcare Products, Inc. | LZA |
| Jun 19, 2008 | K080536 | MICRO-TOUCH NITRAFREE Ansell Healthcare Products, LLC | LZA |
| Mar 6, 2008 | K070800 | LIFESTYLES LUBRICATED POLYISOPRENE LATEX MALE CONDOM Ansell Healthcare Products, LLC | MOL |
| Dec 13, 2007 | K071746 | DERMA PRENE PI OR ISOTOUCH GREEN STERILE POWDER-FREE SYNTHETIC POLYISOPRENE SURGICAL GLOVES Ansell Healthcare Products, LLC | KGO |
| Aug 17, 2005 | K051793 | ENCORE STERILE POWDER-FREE LATEX SURGICAL GLOVE WITH PROPRIETARY COATING (CONTAINING GLYCERINE) Ansell Healthcare Products, LLC | KGO |
| Jan 19, 2005 | K043508 | DERMA PRENE ULTRA POWDER-FREE POLYCHLOROPRENE SYNTHETIC SURGICAL GLOVES (CHEMOTHERAPY USE) Ansell Healthcare Products, LLC | KGO |
| Dec 6, 2004 | K042817 | MICRO-TOUCH SMOOTH NITRILE POWDER-FREE BLUE EXAMINATION GLOVES (CHEMOTHERAPY USE) Ansell Healthcare Products, Inc. | LZA |
| Nov 13, 2002 | K023153 | MICRO-TOUCH NEXT STEP POWDER FREE MEDICAL EXAMINATION GLOVES WITH ALOE AND GLYCEROL Ansell Healthcare Products, Inc. | LYY |
| Nov 13, 2001 | K013604 | MODIFICATION TO: ULTRALON (R) POWDER FREE LATEX SURGICAL GLOVES Ansell Healthcare Products, Inc. | KGO |
| Nov 13, 2001 | K013603 | MODIFICATION TO:MICRO TOUCH (R) POWDER FREE LATEX SURGICAL GLOVES , MODEL STYLE 65 Ansell Healthcare Products, Inc. | KGO |
| Jun 21, 2001 | K011593 | MICRO-TOUCH NITRILE POWDER FREE SYNTHETIC MEDICAL EXAMINATION GLOVES, COLOR BLUE NON-STERILE Ansell Healthcare Products, Inc. | LZA |
| May 31, 2001 | K010961 | X-TENDA CUFF POWDER FREE NON-STERILE LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) Ansell Healthcare Products, Inc. | LYY |
| Jan 16, 2001 | K003771 | ENCORE POWDER-FREE LATEX SURGICAL GLOVES, ORTHOPAEDIC WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) Ansell Healthcare Products, Inc. | KGO |
| Dec 22, 2000 | K003769 | ENCORE MICROPTIC POWDER FREE LATEX SURGICAL GLOVES, MODEL 87 Ansell Healthcare Products, Inc. | KGO |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 11, 2023 | Ansell Healthcare Products LLC NOVAPLUS GAMMEX NON-LATEX PI GREEN Surgical gloves, REF: V20685255 through V20685290 Open, Classified |
KGO | K111139 |
| Oct 11, 2023 | Ansell Healthcare Products LLC GAMMEX NON-LATEX PI GREEN Surgical gloves, REF: 20685255 through 20685290 Open, Classified |
KGO | K111139 |
| Feb 19, 2022 | Ansell Healthcare Products LLC Gammex Non-Latex PI Green PI-KARE Skin-friendly PI Technology polyisoprene surgical gloves 7 1/2 Open, Classified |
KGO | K111139 |
| Aug 19, 2020 | Ansell Healthcare Products LLC 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 pre Terminated |
LYY | K974424 |
| Oct 24, 2016 | Ansell Healthcare Products LLC 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, Terminated |
KGO | K984558 |
| Feb 20, 2013 | Ansell Healthcare Products LLC 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 cond Terminated |
HIS | K120394 |
| Jan 24, 2013 | Ansell Healthcare Products LLC 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. Terminated |
HIS | K000408 K941258 +1 |
| Aug 31, 2011 | Ansell Healthcare Products LLC 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 Terminated |
LZC | K032374 |
| Aug 31, 2011 | Ansell Healthcare Products LLC MICRO-TOUCH(R), L (indicating size large), NITRILE, Powder Free, Medical Examination Gloves, REF 6034303, 200 Pieces, Manufactured for: Ansell Healthcare - Made in Malaysia Terminated |
LZC | K032374 |
| Aug 31, 2011 | Ansell Healthcare Products LLC MICRO-TOUCH(R), M (indicating size medium), NITRILE, Powder Free, Medical Examination Gloves, REF 6034302, 200 Pieces, Manufactured for: Ansell Healthcare - Made in Malaysia Terminated |
LZC | K032374 |
| Aug 31, 2011 | Ansell Healthcare Products LLC MICRO-TOUCH(R), S (indicating size small), NITRILE, Powder Free, Medical Examination Gloves, REF 6034301, 200 Pieces, Manufactured for: Ansell Healthcare - Made in Malaysia Terminated |
LZC | K032374 |
| Jul 18, 2011 | Ansell Healthcare Products LLC 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
Surgica Terminated |
NPD | K051793 |
| Jul 18, 2011 | Ansell Healthcare Products LLC 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
Sur Terminated |
NPD | K051793 |
| Jul 18, 2011 | Ansell Healthcare Products LLC 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
Surgica Terminated |
NPD | K051793 |
| Jul 18, 2011 | Ansell Healthcare Products LLC 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
Sur Terminated |
NPD | K051793 |
| Jul 18, 2011 | Ansell Healthcare Products LLC 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
Surgica Terminated |
NPD | K051793 |
| Jul 18, 2011 | Ansell Healthcare Products LLC 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
Sur Terminated |
NPD | K051793 |
| Jul 18, 2011 | Ansell Healthcare Products LLC 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
Surgica Terminated |
NPD | K051793 |
| Jul 18, 2011 | Ansell Healthcare Products LLC 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
Sur Terminated |
NPD | K051793 |
| Dec 15, 2010 | Ansell Healthcare Products LLC 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 Terminated |
KGO | K000295 |
| Jul 24, 2009 | Ansell Healthcare Products LLC 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 La Terminated |
KGO | K984558 |
| Jul 24, 2009 | Ansell Healthcare Products LLC 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 Sr Terminated |
KGO | K984558 |
| Jul 24, 2009 | Ansell Healthcare Products LLC 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 La Terminated |
KGO | K984558 |
| Jul 24, 2009 | Ansell Healthcare Products LLC 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 S Terminated |
KGO | K984558 |
| Jul 24, 2009 | Ansell Healthcare Products LLC 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 La Terminated |
KGO | K984558 |
| Jul 24, 2009 | Ansell Healthcare Products LLC Ansell, Derma Prene Ultra, Powder-Free, Smooth Surgical Gloves, REF 8513, Size 6 1/2, 4 boxes of 50, Sterile, Distributed by Ansell Healthcare, 1635 Industrial Road, Dothan, AL, 36303, USA, Made in Sr Terminated |
KGO | K984558 |
| Jul 24, 2009 | Ansell Healthcare Products LLC Ansell, Derma Prene Ultra, Powder-Free, Smooth Surgical Gloves, REF 8512, Size 6, 4 boxes of 50, Sterile, Distributed by Ansell Healthcare, 1635 Industrial Road, Dothan, AL, 36303, USA, Made in Sri La Terminated |
KGO | K984558 |