Data / Medical devices / United States / Ansell Healthcare Products LLC
Ansell Healthcare Products LLC: FDA-registered device maker in Reno, NV, United States, 131 510(k) clearances
Ansell Healthcare Products LLC is registered with the FDA (registration 3011209798) in Reno, NV, United States. It lists 16 device types. The FDA files 131 510(k) clearances under its listings, the newest dated October 20, 2023. 3 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3011209798
- Address
- 2301 Robb Drive, Reno, NV, United States, 89523
- Owner or operator
- ANSELL HEALTHCARE PRODUCTS LLC (8020065)
- Roles
- Manufacturer, Specification developer
- First device listed
- November 21, 2007
- Registered through
- 2026
- Brand names listed
- Cobalt ® N19X, FISHER 19-041-171X, GAMMEX PI PLUS GLOVE-IN-GLOVE SYSTEM TESTED FOR USE WITH CHEMOTHERAPY DRUGS, KIT TURNOVER STAT-PAC, LATEX EXAMINATION GLOVE, POWDER FREE WITH PROTEN CONTENT LABELING CLAIM (50 ug/g or less of total extractable Protein), MICROFLEX MIDKNIGHT MK-296, Micro-Touch Royal Blue, PI Hybrid Micro and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance. Newest 100 of 131.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 20, 2023 | 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 | Ansell Healthcare | accessdata.fda.gov |
| August 28, 2023 | K231435 | KIMTECH Polaris Xtra Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid | LZA | Substantially Equivalent | Kimberly-Clark Corporation | accessdata.fda.gov |
| July 21, 2023 | K231021 | KIMTECH Polaris Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid | LZA | Substantially Equivalent | Kimberly-Clark Corporation | accessdata.fda.gov |
| May 26, 2023 | K213289 | Gammex® PI Plus Glove-in-Glove System Tested For Use with Chemotherapy Drugs | KGO | Substantially Equivalent | Ansell Healthcare Products, LLC | accessdata.fda.gov |
| January 11, 2022 | K212735 | Nitrile disposable examination gloves (Tested for use with Chemotherapy Drugs) | LZA | Substantially Equivalent | Xingyu Medical Tech Co., Ltd. | accessdata.fda.gov |
| December 2, 2021 | K212578 | Nitrile disposable examination gloves | LZA | Substantially Equivalent | Xingyu Medical Tech Co., Ltd. | accessdata.fda.gov |
| October 6, 2021 | K211621 | Latex Surgical Gloves, Powder Free with Protein claim (50 micrograms or less) | KGO | Substantially Equivalent | Careplus (M) Sdn Bhd | accessdata.fda.gov |
| August 20, 2021 | K203705 | Latex Examination Glove, Powder free with Protein Content Labeling Claim (50 ug/g or less of total extractable Protein) | LYY | Substantially Equivalent | Careplus (M) Sdn Bhd | accessdata.fda.gov |
| August 20, 2021 | K201857 | Powder Free Nitrile Examination Glove Black and Dual Color White-Blue | LZA | Substantially Equivalent | Careplus (M) Sdn Bhd | accessdata.fda.gov |
| August 3, 2021 | K210724 | ENCORE Latex Acclaim, Powder Free Latex Surgical Gloves with Protein Content Labeling Claim (50 ug/dm2 per glove of total aqueous extractable protein) and Tested for use with Chemotherapy drugs, GAMMEX Latex Standard, Powder Free Latex Surgical Gloves with Protein Content Labeling Claim (50 ug/dm2 per glove of total aqueous extractable protein) and Tested for use with Chemotherapy drugs | KGO | Substantially Equivalent | Careplus (M) Sdn Bhd | accessdata.fda.gov |
| June 24, 2021 | K210656 | ENCORE Latex Ortho, Powder Free Latex Surgical Gloves with Protein Content Labeling Claim (<50µg/dm2 per glove of total aqueous extractable protein) and Tested for use with Chemotherapy drugs, GAMMEX Latex Ortho, Powder Free Latex Surgical Gloves with Protein Content Labeling Claim (<50 µg/dm2 per glove of total aqueous extractable protein) and Tested for use with Chemotherapy drugs | KGO | Substantially Equivalent | Careplus (M) Sdn Bhd | accessdata.fda.gov |
| June 13, 2021 | 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 | Ansell Healthcare Products, LLC | accessdata.fda.gov |
| May 27, 2021 | K202765 | ENCORE Latex Textured Surgical Gloves, Powder Free with Protein Content Labeling Claim (50 micrograms or less) and Tested for use with Chemotherapy drugs | KGO | Substantially Equivalent | Careplus (M) Sdn Bhd | accessdata.fda.gov |
| June 19, 2020 | K200671 | Microflex Nitrile Patient Examination Gloves with Aloe and Chamomile Blue Green Pink Colored Tested for | LZA | Substantially Equivalent | Ansell Healthcare Products, LLC | accessdata.fda.gov |
| April 10, 2020 | K200072 | KIMTECH Purple Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs, the Opioid Fentanyl, Gastric acid, and Fentanyl in Gastric acid | LZA | Substantially Equivalent | Kimberly-Clark Corporation | accessdata.fda.gov |
| December 30, 2019 | K190241 | Sterile Latex Surgical Glove, Powder Free | KGO | Substantially Equivalent | Careglove Global Sdn. Bhd. | accessdata.fda.gov |
| October 23, 2019 | K183562 | Powder-Free Nitrile Examination Glove (White Colored, Blue Colored, and Black Colored) Tested for Use with Chemotherapy Drugs | LZC | Substantially Equivalent | Encompass Industries Sdn. Bhd. | accessdata.fda.gov |
| June 20, 2019 | K183354 | Powder Free Blue Nitrile Examination Gloves Tested for use with 32 Chemotherapy Drugs and Fentanyl Citrate | LZA | Substantially Equivalent | Gx Corporation Sdn Bhd | accessdata.fda.gov |
| November 20, 2018 | K181857 | Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Low Dermatitis Potential. Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | LZA | Substantially Equivalent | Kossan International Sdn Bhd | accessdata.fda.gov |
| May 15, 2018 | K180476 | Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs | LZC | Substantially Equivalent | Comfort Rubber Gloves Industries Sdn. Bhd. | accessdata.fda.gov |
| March 5, 2018 | K173942 | Blue Non Sterile powder free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs | LZC | Substantially Equivalent | Central Medicare Sdn Bhd | accessdata.fda.gov |
| December 29, 2017 | K171737 | Micro Touch Denta Glove Nitrile Hydrasoft Patient Examination Gloves | LZA | Substantially Equivalent | Ansell Healthcare Products, LLC | accessdata.fda.gov |
| September 26, 2017 | K172015 | POWDER FREE NITRILE EXAMINATION GLOVES, BLUE (COLORED) | LZA | Substantially Equivalent | Careglove Global Sdn. Bhd. | accessdata.fda.gov |
| July 24, 2017 | K162858 | NITRILECARE NITRILE EXAMINATION GLOVES POWDER FREE, BLUE, CHEMOTEST | LZC | Substantially Equivalent | Careplus (M) Sdn Bhd | accessdata.fda.gov |
| July 20, 2017 | K171616 | Xingyu Powder Free Nitrile Patient Examination Gloves, Blue color | LZA | Substantially Equivalent | Shandong Xingyu Gloves Co., Ltd. | accessdata.fda.gov |
| July 14, 2017 | K170686 | Nitrile Examination Gloves, Powder Free [Purple] Tested for Use with Chemotherapy Drugs | LZA | Substantially Equivalent | Brightway Holdings Sdn. Bhd. | accessdata.fda.gov |
| April 21, 2017 | K162294 | BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12, POWDER FREE, [PURPLE] TESTED FOR USE WITH CHEMOTHERAPY DRUGS | LZA | Substantially Equivalent | Brightway Holdings Sdn. Bhd. | accessdata.fda.gov |
| March 31, 2017 | K162186 | BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12, POWDER FREE, [STERLING/GREY] WITH CHEMOTHERAPY CLAIM | LZC | Substantially Equivalent | Brightway Holdings Sdn. Bhd. | accessdata.fda.gov |
| February 6, 2017 | K162923 | NITRILE POWDER FREE EXAMINATION GLOVE TESTED FOR USE WITH CHEMOTHERAPY DRUGS - AQUA BLUE; NITRILE POWDER FREE EXAMINATION GLOVE TESTED FOR USE WITH CHEMOTHERAPY DRUGS - VIOLET BLUE; NITRILE POWDER FREE EXAMINATION GLOVE TESTED FOR USE WITH CHEMOTHERAPY DRUGS - DARK BLUE; NITRILE POWDER FREE EXAMINATION GLOVE TESTED FOR USE WITH CHEMOTHERAPY DRUGS - DARK VIOLET BLUE | LZA | Substantially Equivalent | Hartalega NGC Sdn. Bhd. | accessdata.fda.gov |
| January 5, 2017 | K162146 | Brightway Brand Nitrile Examination Gloves, Powder Free (Lavender) | LZA | Substantially Equivalent | Brightway Holdings Sdn. Bhd. | accessdata.fda.gov |
| December 21, 2016 | K161215 | Brightway Brand Nitrile Examination Gloves, Powder Free, [Sterling/Grey] Tested For Use With Chemotherapy Drugs | LZA | Substantially Equivalent | Brightway Holdings Sdn. Bhd. | accessdata.fda.gov |
| October 28, 2016 | K160974 | Gammex Cut-Resistant Glove Liner | KGO | Substantially Equivalent | Ansell Healthcare Products, LLC | accessdata.fda.gov |
| September 9, 2016 | K161187 | EMG Blue Nitrile Examination Gloves Powder Free with Tested for use with Chemotherapy Drugs | LZA | Substantially Equivalent | Eco Medi Glove Sdn. Bhd. | accessdata.fda.gov |
| August 4, 2016 | K161006 | Latex Powder Free Polymer Coated Examination Glove with Protein Labeling Claim of 50 Microgram or Less Per Gram of Glove | LYY | Substantially Equivalent | Hartalega Sdn Bhd | accessdata.fda.gov |
| August 3, 2016 | K151750 | Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Powder Free Nitrile Patient Examination Glove, White Colored, Non-Sterile | LZA | Substantially Equivalent | Kossan International Sdn Bhd | accessdata.fda.gov |
| August 2, 2016 | K151824 | Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-sterile, Low Dermatitis Potential, and Tested for Use with Chemotherapy Drugs, Powder Free Nitrile Patient Examination Glove, White Colored, Non-sterile, Low Dermatitis Potential, and Tested for Use with Chemotherapy Drugs | LZA | Substantially Equivalent | Kossan International Sdn Bhd | accessdata.fda.gov |
| April 21, 2016 | K152222 | NITRILE BLUE POWDER FREE EXAMINATION GLOVES tested for use with Chemotheraphy Drugs | LZC | Substantially Equivalent | Gmp Medicare Sdn Bhd (F25) | accessdata.fda.gov |
| March 9, 2016 | K152712 | Nitrile Powder Free Patient Examination Gloves, Blue Color | LZA | Substantially Equivalent | Zhonghong Pulin Medical Products Co., Ltd. | accessdata.fda.gov |
| March 9, 2016 | K151694 | Gammex PI Hybrid Surgical Gloves | KGO | Substantially Equivalent | Ansell Healthcare Products, LLC | accessdata.fda.gov |
| February 25, 2016 | K152593 | LATEX EXAMINATION GLOVE POWDER FREE | LYY | Substantially Equivalent | Careplus (M) Sdn Bhd | accessdata.fda.gov |
| October 21, 2015 | K151836 | NITRILE POWDER FREE EXAMINATION GLOVES-PINK, NITRILE POWDER FREE EXAMINATION GLOVES-GREEN,NITRILE POWDER FREE EXAMINATION GLOVES-ORANGE, NITRILE POWDER FREE EXAMINATION GLOVES-BLACK | LZA | Substantially Equivalent | Hartalega NGC Sdn. Bhd. | accessdata.fda.gov |
| February 9, 2015 | K142858 | POWDER FREE NITRILE EXAMINATION GLOVE, WHITE (colored) | LZA | Substantially Equivalent | Careplus (M) Sdn Bhd | accessdata.fda.gov |
| January 16, 2015 | K142862 | POWDER FREE NITRILE EXAMINATION GLOVE, BLUE (Colored). | LZA | Substantially Equivalent | Careplus (M) Sdn Bhd | accessdata.fda.gov |
| January 16, 2015 | K142283 | Non-Sterile, Powder Free Nitrile Examination Gloves (Blue, Black and White Color) | LZA | Substantially Equivalent | Yty Industry (Manjung) Sdn Bhd | accessdata.fda.gov |
| July 24, 2014 | K140890 | NITRILE POWDER FREE EXAMINATION GLOVES (WHITE/DAWN BLUE/DARK VIOLET BLUE (DVBU)/COBALT BLUE (CBLU) | LZA | Substantially Equivalent | Hartalega NGC Sdn. Bhd. | accessdata.fda.gov |
| July 18, 2014 | K133699 | POWDER FREE GREEN, BLUE AND BROWN POLYCHLOROPRENE EXAMINATION GLOVES | LZA | Substantially Equivalent | Pt. Smartglove Indonesia | accessdata.fda.gov |
| June 20, 2014 | K140610 | NITRILE POWDER FREE EXAMINATION GLOVE - AQUA BLUE (ABLU) / VIOLET BLUE (VBLU) / DARK BLUE (DKBU) | LZA | Substantially Equivalent | Hartalega NGC Sdn. Bhd. | accessdata.fda.gov |
| April 8, 2014 | K133949 | POWDER FREE NITRILE PATIENT EXAMINATION GLOVE,BLUE AND ORANGE COLORED,NON-STERILE TESTED FOR USE WITH CHEMOTHERAPY DRUGS | LZA | Substantially Equivalent | Top Calibre Sdn Bhd | accessdata.fda.gov |
| January 31, 2014 | K132221 | POWDER-FREE VINYL PATIENT EXAMINATION GLOVES | LYZ | Substantially Equivalent | Shandong Haoyu Medical Products Co., Ltd. | accessdata.fda.gov |
| January 7, 2014 | K131832 | POWDER-FREE VINYL PATIENT EXAMINATION GLOVES | LYZ | Substantially Equivalent | Shandong Binxiang Medical Products Co., Ltd. | accessdata.fda.gov |
| October 25, 2012 | K121594 | COLORED POWDER FREE LATEX EXAMINATION GLOVE (WHITE AND BLUE) | LYY | Substantially Equivalent | Tekmedic (M) Sdn Bhd | accessdata.fda.gov |
| May 14, 2012 | K120692 | LATEX EXAMINATION GLOVES (POWDER FREE) | LYY | Substantially Equivalent | Top Calibre Sdn Bhd | accessdata.fda.gov |
| September 2, 2011 | K111139 | DERMA PRENE ISOTOUCH GREEN STERILE POWDER-FREE POLYISOPRENE SURGICAL GOVES, TESTED FOR U | KGO | Substantially Equivalent | Ansell Healthcare Products, Inc. | accessdata.fda.gov |
| August 12, 2011 | K110758 | NITRILE POWDER FREE EXAMINATION GLOVES | LZA | Substantially Equivalent | Hartalega Sdn Bhd | accessdata.fda.gov |
| July 14, 2011 | K110960 | ROYAL IMPERIAL NITRILE EXAMINATION GLOVES TEXTURED POWDER-FREE | LZA | Substantially Equivalent | Koon Seng Sdn Bhd | accessdata.fda.gov |
| July 7, 2011 | K103714 | ENCORE ACCLAIM STERILE POWDER-FREE LATEX SURGICAL GLOVES, TESTED FOR USE WITH CHEMOTHERA | KGO | Substantially Equivalent | Ansell Healthcare Products, LLC | accessdata.fda.gov |
| June 15, 2011 | K110297 | POWDER FREE NITRILE (BLACK) EXAMINATION GLOVES | LZA | Substantially Equivalent | Comfort Rubber Gloves Industries Sdn. Bhd. | accessdata.fda.gov |
| November 29, 2010 | K102790 | POWDER FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE COLORED NON-STERILE (LOW DERAMATITIS POTENTIAL AND CHEMOTHERAPY DRUG | LZC | Substantially Equivalent | Perusahaan Getah Asas Sdn. Bhd. | accessdata.fda.gov |
| November 2, 2010 | K102074 | POWDER FREE NITRILE EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS, BLUE (SG) | LZA | Substantially Equivalent | Gx Corporation Sdn Bhd | accessdata.fda.gov |
| October 4, 2010 | K102096 | POWDER FREE NITRILE EXAMINATION GLOVES, BLUE | LZA | Substantially Equivalent | Syntex Healthcare Products Co., Ltd. | accessdata.fda.gov |
| September 3, 2010 | K101799 | POWDER FREE LATEX EXAMINATION GLOVES BLUE (COLORED), NON-STERILE, WITH PROTEIN LABELING CLAIM OF 50UG PER DM2 OF GLOVE | LYY | Substantially Equivalent | Wear Safe (Malaysia) Sdn. Bhd. | accessdata.fda.gov |
| June 25, 2010 | K100694 | COLORED POWDER FREE AND POLYMER COATED EXAMINATION GLOVE (BLUE, BLACK AND PINK) WITH A PROTEIN CLAIM OF LESS THAN | LYY | Substantially Equivalent | Tekmedic (M) Sdn Bhd | accessdata.fda.gov |
| May 4, 2010 | K100139 | SAFE LIFE N95 RESPIRATOR AND SURGICAL MASK, MODELS B130 AND B150 | MSH | Substantially Equivalent | Safelife Corp. | accessdata.fda.gov |
| March 4, 2010 | K093523 | MICRO-TOUCH NITRILE | LZA | Substantially Equivalent | Ansell Healthcare Products, LLC | accessdata.fda.gov |
| February 23, 2010 | K092681 | POWDERED LATEX EXAMINATION GLOVES, NON-STERILE | LYY | Substantially Equivalent | Khai Hoan Joint Stock Company | accessdata.fda.gov |
| February 12, 2010 | K093696 | SR GLOVE, NU GLOVE, HIGHSTRESS MODEL 801, MODEL 802, MODEL 803 | LZA | Substantially Equivalent | Central Medicare Sdn Bhd | accessdata.fda.gov |
| September 21, 2009 | K092327 | MICRO-TOUCH NITRA FREE | LZA | Substantially Equivalent | Ansell Healthcare Products, LLC | accessdata.fda.gov |
| September 4, 2009 | K091652 | NITRILE POWDER FRE EXAMINATION GLOVES (BLUE) TESTED FOR USE WITH CHEMOTHREAPY DRUGS | LZA | Substantially Equivalent | Hartalega Sdn Bhd | accessdata.fda.gov |
| July 8, 2009 | K091431 | POWDER-FREE, YELLOW VINYL PATIENT EXAMINATION GLOVES | LYZ | Substantially Equivalent | Zibo Yusheng Plastic Products Co., Ltd. | accessdata.fda.gov |
| April 3, 2009 | K090327 | POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVES, STERILE, WITH PROTEIN LABELING CLAIM OF 50 UG PER DM2 OF GLOVE | LYY | Substantially Equivalent | Wear Safe (Malaysia) Sdn. Bhd. | accessdata.fda.gov |
| February 10, 2009 | K083624 | POWDER FREE NITRILE (BLUE AND WHITE) EXAMINATION GLOVES | LZA | Substantially Equivalent | Comfort Rubber Gloves Ind. Sdn. Bhd. | accessdata.fda.gov |
| December 3, 2008 | K081592 | POWDER FREE NITRILE (BLUE AND WHITE) EXAMINATION GLOVES | LZA | Substantially Equivalent | Quality Gallant Sdn. Bhd. | accessdata.fda.gov |
| November 10, 2008 | K082457 | MICRO-TOUCH NITRATEX STERILE NITRILE POWDER-FREE BLUE EXAMINATION GLOVES (CHEMOTHERAPY USE) | LZA | Substantially Equivalent | Ansell Healthcare Products, Inc. | accessdata.fda.gov |
| June 19, 2008 | K080536 | MICRO-TOUCH NITRAFREE | LZA | Substantially Equivalent | Ansell Healthcare Products, LLC | accessdata.fda.gov |
| May 23, 2008 | K080937 | POWDER FREE NITRILE EXAMINATION GLOVE, ORANGE | LZA | Substantially Equivalent | Gx Corporation Sdn Bhd | accessdata.fda.gov |
| December 13, 2007 | K071746 | DERMA PRENE PI OR ISOTOUCH GREEN STERILE POWDER-FREE SYNTHETIC POLYISOPRENE SURGICAL GLOVES | KGO | Substantially Equivalent | Ansell Healthcare Products, LLC | accessdata.fda.gov |
| March 20, 2007 | K063627 | POWDER FREE NITRILE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS (BLUE) | LZA | Substantially Equivalent | Smart Glove Corp. Sdn Bhd | accessdata.fda.gov |
| February 22, 2007 | K070076 | POWDER FREE VINYL PATINET EXAMINATION GLOVES, CLEAR (NON-COLORED) | LYZ | Substantially Equivalent | Jiangsu Cureguard Glove Co., Ltd. | accessdata.fda.gov |
| November 2, 2006 | K062917 | STERILE AND NON-STERILE POWDER-FREE LATEX PATIENT EXAMINATION GLOVE, WITH EXTRACTABLE PROTEIN CONTENT LABELING CLAIM (50 | LYY | Substantially Equivalent | Wear Safe Malaysia Sdn. Bhd. | accessdata.fda.gov |
| July 17, 2006 | K061553 | NON-STERILE, POWDER-FREE BLACK NITRILE EXAMINATION GLOVES | LZA | Substantially Equivalent | Yty Industry (Manjung) Sdn Bhd | accessdata.fda.gov |
| May 16, 2006 | K060775 | POWDER-FREE LATEX PATIENT EXAMINATION GLOVE,WITH EXTRACTABLE PROTEIN CONTENT LABELLING CLAIM (50 MICROGRAM PER GRAM OF | LYY | Substantially Equivalent | Kossan Latex Industries(M)Sdn Bhd | accessdata.fda.gov |
| August 17, 2005 | K051793 | ENCORE STERILE POWDER-FREE LATEX SURGICAL GLOVE WITH PROPRIETARY COATING (CONTAINING GLYCERINE) | KGO | Substantially Equivalent | Ansell Healthcare Products, LLC | accessdata.fda.gov |
| August 12, 2005 | K051777 | NITRILE POWDER FREE EXAMINATION GLOVES (BLUE) | LZA | Substantially Equivalent | Hartalega Sdn Bhd | accessdata.fda.gov |
| December 1, 2004 | K041913 | POWDERFREE COLORED AND FLAVORED CHLOREPRENE PATIENT EXAMINATION GLOVES TESTED FOR CHEMO USE | LZA | Substantially Equivalent | Pt. Medisafe Technologies | accessdata.fda.gov |
| September 30, 2004 | K042226 | SYNTEX POWDER-FREE NITRILE EXAMINATION GLOVE, TESTED FOR CHEMOTHERAPY | LZA | Substantially Equivalent | Syntex Healthcare Products Co., Ltd. | accessdata.fda.gov |
| April 22, 2004 | K040607 | MODIFICATION TO POWDERFREE COLORED AND FLAVORED CHLOROPRENE PATIENT EXAMINATION GLOVES | LZA | Substantially Equivalent | Pt. Medisafe Technologies | accessdata.fda.gov |
| October 29, 2003 | K032024 | POWDER-FREE NITRILE EXAMINATION GLOVES, BLUE COLOR (TESTED FOR USE WITH CHEMOTHERAPY DRUGS) | LZA | Substantially Equivalent | Shen Wei (Usa), Inc. | accessdata.fda.gov |
| October 22, 2003 | K032374 | POWDER-FREE NITRILE PATIENT CHEMOTHERAPY EXAMINATION GLOVE, BLUE COLORED | LZC | Substantially Equivalent | Perusahaan Getah Asas Sdn. Bhd. | accessdata.fda.gov |
| February 19, 2003 | K022814 | MULTIPLE NITRILE EXAMINATION GLOVES (POWDERED) | LZA | Substantially Equivalent | Pt. Smartglove Indonesia | accessdata.fda.gov |
| November 13, 2002 | K023153 | MICRO-TOUCH NEXT STEP POWDER FREE MEDICAL EXAMINATION GLOVES WITH ALOE AND GLYCEROL | LYY | Substantially Equivalent | Ansell Healthcare Products, Inc. | accessdata.fda.gov |
| October 3, 2002 | K022904 | DERMAGRIP-N/MULTIPLE/WRP ASIA PACIFIC SDN BHD POWDER FREE NITRILE EXAMINATION GLOVES, NON-STERILE | LZA | Substantially Equivalent | Wrp Asia Pacific Sdn. Bhd. | accessdata.fda.gov |
| February 26, 2002 | K020493 | SYNTEX POWDER-FREE NITRILE EXAMINATION GLOVE | LZA | Substantially Equivalent | Syntex Healthcare Products Co., Ltd. | accessdata.fda.gov |
| July 9, 2001 | K011728 | BRIGHTWAY BRAND POWDER FREE LATEX EXAMINATION GLOVES, BLUE NON-STERILE, PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS) ( | LYY | Substantially Equivalent | Brightway Holdings Sdn. Bhd. | accessdata.fda.gov |
| April 3, 2001 | K010110 | POWDER-FREE NITRILE EXAMINATION GLOVES, WHITE | LZA | Substantially Equivalent | Shen Wei (Usa), Inc. | accessdata.fda.gov |
| March 30, 2001 | K010097 | POWDER-FREE NITRILE EXAMINATION GLOVES WITH ALOE VERA, GREEN (TESTED FOR USE WITH CHEMOTHERAPY DRUGS) | LZA | Substantially Equivalent | Shen Wei (Usa), Inc. | accessdata.fda.gov |
| February 9, 2001 | K003985 | POWDERFREE NITRILE PATIENT EXMINATION GLOVE | LZA | Substantially Equivalent | Guthrie Medicare Products (Melaka) Sdn Bhd | accessdata.fda.gov |
| May 3, 2000 | K991422 | POWDER-FREE NITRILE EXAMINATION GLOVE (TESTED FOR USE WITH CHEMOTHERAPY DRUGS) | LZA | Substantially Equivalent | Shen Wei (Usa), Inc. | accessdata.fda.gov |
| February 16, 2000 | K000295 | ENCORE MICROPTIC POWDER FREE LATEX SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) | KGO | Substantially Equivalent | Ansell Perry | accessdata.fda.gov |
| February 7, 2000 | K994250 | TEKMEDIC POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) | LYY | Substantially Equivalent | Tekmedic (M) Sdn Bhd | accessdata.fda.gov |
| February 7, 2000 | K993876 | POWDER-FREE NITRILE EXAMINATION GLOVES WITH ALOE VERA | LZA | Substantially Equivalent | Shen Wei (Usa), Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| August 3, 2023 | 93045 | Class II | Ongoing | GAMMEX NON-LATEX PI GREEN Surgical gloves, REF: 20685255 through 20685290 | Some surgical glove sterile pouches were not completely sealed. | accessdata.fda.gov |
| February 19, 2022 | 89691 | Class II | Ongoing | 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. | accessdata.fda.gov |
| August 19, 2020 | 86352 | Class II | Terminated | 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 b | Examination gloves were shipped inadvertently, without to verify barrier integrity. | accessdata.fda.gov |
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- All makers of Tourniquet, Nonpneumatic
- All makers of Support, Patient Position
Updated October 20, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.