Data / Medical devices / Canada / Ansell Canada Inc.
Ansell Canada Inc.: FDA-registered device maker in Cowansville Quebec, Canada, 79 510(k) clearances
Ansell Canada Inc. is registered with the FDA (registration 3003199637) in Cowansville Quebec, Canada. It lists 8 device types. The FDA files 79 510(k) clearances under its listings, the newest dated May 26, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3003199637
- Address
- 105 Rue Lauder, Cowansville Quebec, Canada, J2K 2K8
- Owner or operator
- ANSELL HEALTHCARE PRODUCTS LLC (8020065)
- Roles
- Exporter to the US
- 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, Micro-Touch Royal Blue, POWDER FREE NITRILE EXAMINATION GLOVE WHITE (colored)
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessory, Surgical Apparel | LYU | 1 | Exporter to the US | accessdata.fda.gov |
| Latex Patient Examination Glove | LYY | 1 | Exporter to the US | accessdata.fda.gov |
| Medical Glove, Specialty | LZC | 1 | Exporter to the US | accessdata.fda.gov |
| Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs | OPJ | 1 | Exporter to the US | accessdata.fda.gov |
| Polymer Patient Examination Glove | LZA | 1 | Exporter to the US | accessdata.fda.gov |
| Respirator, Surgical | MSH | 2 | Exporter to the US | accessdata.fda.gov |
| Surgeon'S Gloves | KGO | 1 | Exporter to the US | accessdata.fda.gov |
| Vinyl Patient Examination Glove | LYZ | 1 | Exporter to the US | accessdata.fda.gov |
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.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| 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 |
| 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 |
| October 28, 2016 | K160974 | Gammex Cut-Resistant Glove Liner | KGO | Substantially Equivalent | Ansell Healthcare Products, LLC | 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 |
| February 5, 2015 | K141982 | DERMAGRIP POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVES, NON-STERILE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS | LZC | Substantially Equivalent | Wrp Asia Pacific 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 |
| July 3, 2014 | K133689 | POWDER FREE POLYCHLOROPRENE LIGHT WIEGHT EXAMINATIONGLOVES- GREEN,BLUE AND PINK | LZA | Substantially Equivalent | Pt. Medisafe Technologies | 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 |
| March 5, 2013 | K123819 | MULTIPLE NAME | 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 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 |
| 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 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 |
| 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 |
| 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 |
| July 24, 2007 | K071119 | POWDER FREE NITRILE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS (BLUE, WHITE) | LZA | Substantially Equivalent | Gx Corporation Sdn Bhd | 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 27, 2007 | K062764 | POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, WHITE (NON-COLORED) AND BLUE COLORED | LZC | Substantially Equivalent | Kossan Latex Industries(M)Sdn Bhd | 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 |
| May 8, 2006 | K060786 | SYNTHETIC (YELLOW) VINYL PATIENT EXAMINATION GLOVE-POWDER FREE | LYZ | Substantially Equivalent | Ever Light Plastic Products Co., Ltd. | 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 |
| March 16, 2005 | K050214 | NITRILE POWDER FREE EXAMINATION GLOVES (WHITE) | 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 |
| April 27, 2004 | K040702 | SYNTHETIC (YELLOW) VINYL PATIENT EXAMINATION GLOVES - POWDER FREE | LYZ | Substantially Equivalent | Grand Work Plastic 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 22, 2003 | K032374 | POWDER-FREE NITRILE PATIENT CHEMOTHERAPY EXAMINATION GLOVE, BLUE COLORED | LZC | Substantially Equivalent | Perusahaan Getah Asas Sdn. Bhd. | accessdata.fda.gov |
| July 25, 2003 | K031580 | NON-STERILE, POWDER-FREE, BLUE COLOR NITRILE EXAMINATION GLOVE | LZA | Substantially Equivalent | Green Prospect 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 |
| 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 | K993876 | POWDER-FREE NITRILE EXAMINATION GLOVES WITH ALOE VERA | LZA | Substantially Equivalent | Shen Wei (Usa), Inc. | accessdata.fda.gov |
| January 31, 2000 | K993857 | THE ORIGINAL PERRY, STYLE 42 WHITE LATEX POWDERED SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (60 MICROGRAMS OR | KGO | Substantially Equivalent | Ansell Perry | accessdata.fda.gov |
| October 29, 1999 | K992953 | SURGEONS GLOVE, BROWN LATEX POLYMER COATED, POWDER FREE WITH PROTEIN LABEL CLAIM | KGO | Substantially Equivalent | Ansell Perry | accessdata.fda.gov |
| March 23, 1999 | K990013 | EVERGREEN NON-STERILE POWDER-FREE, COLORED NITRILE EXAMINATION GLOVES | LZA | Substantially Equivalent | Yty Industry (Manjung) Sdn Bhd | accessdata.fda.gov |
| February 26, 1999 | K984558 | DERMA PRENE POWDER-FREE SYNTHETIC SURGICAL GLOVES (CHEMOTHERAPY USE) | KGO | Substantially Equivalent | Ansell Perry | accessdata.fda.gov |
| January 26, 1999 | K983145 | TEXTURED POWDER-FREE LATEX EXAM GLOVES WITH ALOE VERA AND PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) | LYY | Substantially Equivalent | Shen Wei (Usa), Inc. | accessdata.fda.gov |
| December 14, 1998 | K983489 | ENCORE MARK IV POWDER FREE POLYMER COATED LATEX SURGICAL GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LE) | KGO | Substantially Equivalent | Ansell Perry | accessdata.fda.gov |
| November 30, 1998 | K982453 | NON-STERILE E.P. LATEX EXAMINATION GLOVE | LYY | Substantially Equivalent | Ansell Perry | accessdata.fda.gov |
| November 5, 1998 | K981064 | POWDERFREE COLORED AND FLAVORED CHLOROPRENE PATIENT EXAMINATION GLOVES | LZA | Substantially Equivalent | P.T. Irama Dinamika Latex | accessdata.fda.gov |
| October 15, 1998 | K982872 | TG MEDICAL POWDER-FREE LATEX EXAMINATION GLOVE PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS) | LYY | Substantially Equivalent | Tg Medical Sdn. Bhd. | accessdata.fda.gov |
| April 23, 1998 | K974424 | COMFORT RUBBER GLOVES INDUSTRIES SDN BHD | LYY | Substantially Equivalent | Comfort Rubber Gloves Industries Sdn. Bhd. | accessdata.fda.gov |
| December 11, 1997 | K973778 | POLYMER COATED POWDER-FREE LATEX EXAMINATION GLOVES | LYY | Substantially Equivalent | Hartalega Sdn Bhd | accessdata.fda.gov |
| October 24, 1997 | K972621 | PROFEEL POWDER FREE SURGICAL GLOVES (PROTEIN CONTENT LABELING) | KGO | Substantially Equivalent | Wembley Rubber Products (M) Sdn Bhd | accessdata.fda.gov |
| May 6, 1997 | K970794 | LATEX PATIENT EXAMINATION (POWDERFREE GLOVE) | LYY | Substantially Equivalent | Siam Sempermed Corp., Ltd. | accessdata.fda.gov |
| February 7, 1997 | K964148 | PATIENT EXAMINATION GLOVES; CHLORINATED POWDERFREE NITRILE EXAMINATION GLOVES | LZA | Substantially Equivalent | Hartalega Sdn Bhd | accessdata.fda.gov |
| October 11, 1996 | K953213 | COMFIT (POWDER FREE EXAMINATION GLOVES (HYPOALLERGENIC, LOW PROTEIN, BEADED) | LYY | Substantially Equivalent | Wembley Rubber Products (M) Sdn Bhd | accessdata.fda.gov |
| July 26, 1996 | K962188 | COMFIT POWDER FREE BLUE EXAMINATION GLOVES (HYPOALLERGENIC, LOW PROTEIN) | LYY | Substantially Equivalent | Wembley Rubber Products (M) Sdn Bhd | accessdata.fda.gov |
| June 27, 1996 | K953590 | COMFIT | LYY | Substantially Equivalent | Wembley Rubber Products (M) Sdn Bhd | accessdata.fda.gov |
| January 23, 1996 | K955029 | POWDER-FREE LATES EXAM GLOVES WITH PROTEIN CLAIM | LYY | Substantially Equivalent | Shen Wei (Usa), Inc. | accessdata.fda.gov |
| December 15, 1995 | K952051 | SCINITREX (POWDER FREE NITRILE EXAMINATION GLOVES) | LZA | Substantially Equivalent | Wembley Rubber Products (M) Sdn Bhd | accessdata.fda.gov |
| September 29, 1993 | K930602 | LATEX EXAMINATION GLOVES, POWDER FREE | LYY | Substantially Equivalent | Tekmedic (M) Sdn Bhd | accessdata.fda.gov |
| January 28, 1991 | K904769 | SENSITOUCH | KGO | Substantially Equivalent | Ansell Intl. | accessdata.fda.gov |
Compare with other makers
- All makers of Polymer Patient Examination Glove
- All makers of Medical Glove, Specialty
- All makers of Latex Patient Examination Glove
- All makers of Surgeon'S Gloves
- All makers of Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs
- All makers of Accessory, Surgical Apparel
Updated May 26, 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.