FDA.reportPublic FDA data

ANSELL HEALTHCARE PRODUCTS LLC

Matched from indexed company URL: Ansell Healthcare

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30099640473009964047ANSELL HEALTHCARE PRODUCTS LLC1Y2026-01-01111 Wood Ave S Suite 210 Iselin NJ US 08830
30112097983011209798ANSELL HEALTHCARE PRODUCTS LLC1Y2026-01-012301 Robb Drive Reno NV US 89523

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00769799205019MICROFLEX - MICROFLEX EV-2050 EVOLUTION ONE SIZE XS (5.5-6.0), Latex Powder-Free Examination Glove7757466600nick.magri@ansell.com
00769799205019MICROFLEX - MICROFLEX EV-2050 EVOLUTION ONE SIZE XS (5.5-6.0), Latex Powder-Free Examination Glove775-470-7106don.cronk@ansell.com
00769799205026MICROFLEX - MICROFLEX EV-2050 EVOLUTION ONE SIZE S (6.5-7.0), Latex Powder-Free Examination Glove775-470-7106don.cronk@ansell.com
00769799205026MICROFLEX - MICROFLEX EV-2050 EVOLUTION ONE SIZE S (6.5-7.0), Latex Powder-Free Examination Glove7757466600nick.magri@ansell.com
00769799205033MICROFLEX - MICROFLEX EV-2050 EVOLUTION ONE SIZE M (7.5-8.0), Latex Powder-Free Examination Glove775-746-6600nick.magri@ansell.com
00769799205033MICROFLEX - MICROFLEX EV-2050 EVOLUTION ONE SIZE M (7.5-8.0), Latex Powder-Free Examination Glove775-470-7106don.cronk@ansell.com
00769799205040MICROFLEX - MICROFLEX EV-2050 EVOLUTION ONE SIZE L (8.5-9.0), Latex Powder-Free Examination Glove775-746-6600nick.magri@ansell.com
00769799205040MICROFLEX - MICROFLEX EV-2050 EVOLUTION ONE SIZE L (8.5-9.0), Latex Powder-Free Examination Glove775-470-7106don.cronk@ansell.com
00769799205057MICROFLEX - MICROFLEX EV-2050 EVOLUTION ONE SIZE XL (9.5-10.0), Latex Powder-Free Examination Glove775-746-6600nick.magri@ansell.com
00769799205057MICROFLEX - MICROFLEX EV-2050 EVOLUTION ONE SIZE XL (9.5-10.0), Latex Powder-Free Examination Glove775-470-7106don.cronk@ansell.com
20076490793184MICROFLEX - MICROFLEX XC-310CP XCEED SIZE M (7.5-8.0), Powder-Free Nitrile Examination Gloves775-746-6600nick.magri@ansell.com
20076490793191MICROFLEX - MICROFLEX XC-310CP XCEED SIZE L (8.5-9.0), Powder-Free Nitrile Examination Gloves775-470-7106don.cronk@ansell.com
20076490793207MICROFLEX - MICROFLEX XC-310CP XCEED SIZE XL (9.5-10.0), Powder-Free Nitrile Examination Gloves775-746-6600nick.magri@ansell.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2192301144343536K994250TEKMEDIC POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)LYY2000-02-07
2192301854826294K993876POWDER-FREE NITRILE EXAMINATION GLOVES WITH ALOE VERALZA2000-02-07
2192301332548607K993857THE ORIGINAL PERRY, STYLE 42 WHITE LATEX POWDERED SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (60 MICROGRAMS ORKGO2000-01-31
2192301834108741K992953SURGEONS GLOVE, BROWN LATEX POLYMER COATED, POWDER FREE WITH PROTEIN LABEL CLAIMKGO1999-10-29
2192301680753861K991422POWDER-FREE NITRILE EXAMINATION GLOVE (TESTED FOR USE WITH CHEMOTHERAPY DRUGS)LZA2000-05-03
2192301369060441K990878BRIGHTWAY BRAND BLUE NITRILE EXAMINATION GLOVES (POWDER FREE)LZA1999-05-21
2192301110624182K990543BRIGHTWAY BRAND POLYMER COATED LATEX EXAMINATION GLOVE (POWDER FREE)LYY1999-04-09
2192301131818658K990539BRIGHTWAY BRAND LATEX EXAMINATION GLOVES (POWDER FREE)LYY1999-04-09
2192301929655961K990013EVERGREEN NON-STERILE POWDER-FREE, COLORED NITRILE EXAMINATION GLOVESLZA1999-03-23
2192301177685800K984558DERMA PRENE POWDER-FREE SYNTHETIC SURGICAL GLOVES (CHEMOTHERAPY USE)KGO1999-02-26
2192301396960487K983489ENCORE MARK IV POWDER FREE POLYMER COATED LATEX SURGICAL GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LE)KGO1998-12-14
2192301617858827K983145TEXTURED POWDER-FREE LATEX EXAM GLOVES WITH ALOE VERA AND PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)LYY1999-01-26
2192301953633970K982877MATANG POWDER-FREE LOW PROTEIN LATEX PATIENT EXAMINATION GLOVELYY1998-11-30
2192301514528081K982872TG MEDICAL POWDER-FREE LATEX EXAMINATION GLOVE PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS)LYY1998-10-15
2192301718438119K982453NON-STERILE E.P. LATEX EXAMINATION GLOVELYY1998-11-30
2192301477665703K982131NITRA-TOUCH POWDER-FREE NITRILE MEDICAL EXAMINATION GLOVELZA1998-10-29
2192301545480849K981064POWDERFREE COLORED AND FLAVORED CHLOROPRENE PATIENT EXAMINATION GLOVESLZA1998-11-05
2192301795394876K974424COMFORT RUBBER GLOVES INDUSTRIES SDN BHDLYY1998-04-23
2192301410569568K973778POLYMER COATED POWDER-FREE LATEX EXAMINATION GLOVESLYY1997-12-11
2192301303240213K972621PROFEEL POWDER FREE SURGICAL GLOVES (PROTEIN CONTENT LABELING)KGO1997-10-24
2192301043277468K971424DERMACLEAN X-AM (PROTEIN LABELING CLAIM) EXAMINATION GLOVESLYY1997-06-04
2192301699877195K970794LATEX PATIENT EXAMINATION (POWDERFREE GLOVE)LYY1997-05-06
1488671939242901K964148PATIENT EXAMINATION GLOVES; CHLORINATED POWDERFREE NITRILE EXAMINATION GLOVESLZA1997-02-07
2192301939242901K964148PATIENT EXAMINATION GLOVES; CHLORINATED POWDERFREE NITRILE EXAMINATION GLOVESLZA1997-02-07
2192301808530077K962188COMFIT POWDER FREE BLUE EXAMINATION GLOVES (HYPOALLERGENIC, LOW PROTEIN)LYY1996-07-26
2192301867674799K955029POWDER-FREE LATES EXAM GLOVES WITH PROTEIN CLAIMLYY1996-01-23
2192301056056547K953590COMFITLYY1996-06-27
2192301522024929K953213COMFIT (POWDER FREE EXAMINATION GLOVES (HYPOALLERGENIC, LOW PROTEIN, BEADED)LYY1996-10-11
2192301424921872K952051SCINITREX (POWDER FREE NITRILE EXAMINATION GLOVES)LZA1995-12-15
2192301149387991K951662COMFIT/BEADED SURGEON'S GLOVEKGO1995-05-17
2192301295679698K943674NEUTRALON LP BROWN LATEX SURGICAL GLOVESKGO1995-02-13
2192301160635213K941900POWDERED LATEX EXAM GLOVESLYY1994-06-21
2192301556366378K930602LATEX EXAMINATION GLOVES, POWDER FREELYY1993-09-29
2192301634480820K904769SENSITOUCHKGO1991-01-28
2192301937960900K850635ANSELL NO POWDER SURGEON'S GLOVESKGO1985-06-26
2192301796888646K231902GAMMEX 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)KGO2023-10-20
2192301311427109K231435KIMTECH™ Polaris™ Xtra Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric AcidLZA2023-08-28
2192301022285498K231021KIMTECH™ Polaris™ Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric AcidLZA2023-07-21
2192301201759637K213289Gammex® PI Plus Glove-in-Glove™ System Tested For Use with Chemotherapy DrugsKGO2023-05-26
2192301313921757K212735Nitrile disposable examination gloves (Tested for use with Chemotherapy Drugs)LZA2022-01-11
2192301762418180K212578Nitrile disposable examination glovesLZA2021-12-02
2192301614915310K211621Latex Surgical Gloves, Powder Free with Protein claim (50 micrograms or less)KGO2021-10-06
2192301935170480K210724ENCORE 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 drugsKGO2021-08-03
2192301127270788K210656ENCORE 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 drugsKGO2021-06-24
2192301917206689K210401Microflex 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 CitrateLZA2021-06-13
1488671068021854K203705Latex Examination Glove, Powder free with Protein Content Labeling Claim (50 ug/g or less of total extractable Protein)LYY2021-08-20
2192301068021854K203705Latex Examination Glove, Powder free with Protein Content Labeling Claim (50 ug/g or less of total extractable Protein)LYY2021-08-20
2192301001317762K202765ENCORE Latex Textured Surgical Gloves, Powder Free with Protein Content Labeling Claim (50 micrograms or less) and Tested for use with Chemotherapy drugsKGO2021-05-27
2192301317856436K201857Powder Free Nitrile Examination Glove Black and Dual Color White-BlueLZA2021-08-20
2192301665333841K200671Microflex Nitrile Patient Examination Gloves with Aloe and Chamomile Blue Green Pink Colored Tested forLZA2020-06-19
2192301276976078K200072KIMTECH Purple Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs, the Opioid Fentanyl, Gastric acid, and Fentanyl in Gastric acidLZA2020-04-10
2192302015571590K190241Sterile Latex Surgical Glove, Powder FreeKGO2019-12-30
2192301262616834K183562Powder-Free Nitrile Examination Glove (White Colored, Blue Colored, and Black Colored) Tested for Use with Chemotherapy DrugsLZC2019-10-23
2192301854224093K183354Powder Free Blue Nitrile Examination Gloves Tested for use with 32 Chemotherapy Drugs and Fentanyl CitrateLZA2019-06-20
2192301044324138K181857Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Low Dermatitis Potential. Tested for Use with Chemotherapy Drugs and Fentanyl CitrateLZA2018-11-20
2192302038569059K180476Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy DrugsLZC2018-05-15
2192301387290462K173942Blue Non Sterile powder free Nitrile Examination Gloves Tested for Use with Chemotherapy DrugsLZC2018-03-05
2192301612789840K172015POWDER FREE NITRILE EXAMINATION GLOVES, BLUE (COLORED)LZA2017-09-26
2192301998922932K171737Micro Touch Denta Glove Nitrile Hydrasoft Patient Examination GlovesLZA2017-12-29
2192301243143104K171616Xingyu Powder Free Nitrile Patient Examination Gloves, Blue colorLZA2017-07-20
2192301399742754K170686Nitrile Examination Gloves, Powder Free [Purple] Tested for Use with Chemotherapy DrugsLZA2017-07-14
2192301370681405K162923NITRILE 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 BLUELZA2017-02-06
2192301591617252K162858NITRILECARE NITRILE EXAMINATION GLOVES POWDER FREE, BLUE, CHEMOTESTLZC2017-07-24
2192301207872476K162294BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12”, POWDER FREE, [PURPLE] TESTED FOR USE WITH CHEMOTHERAPY DRUGSLZA2017-04-21
2192301685616445K162186BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12”, POWDER FREE, [STERLING/GREY] WITH CHEMOTHERAPY CLAIMLZC2017-03-31
2192301466885815K162146Brightway Brand Nitrile Examination Gloves, Powder Free (Lavender)LZA2017-01-05
2192301982871934K161215Brightway Brand Nitrile Examination Gloves, Powder Free, [Sterling/Grey] Tested For Use With Chemotherapy DrugsLZA2016-12-21
2192302031330630K161187EMG Blue Nitrile Examination Gloves Powder Free with Tested for use with Chemotherapy DrugsLZA2016-09-09
2192301748048582K161006Latex Powder Free Polymer Coated Examination Glove with Protein Labeling Claim of 50 Microgram or Less Per Gram of GloveLYY2016-08-04
2192301888531412K160974Gammex Cut-Resistant Glove LinerKGO2016-10-28
2192301585423766K152712Nitrile Powder Free Patient Examination Gloves, Blue ColorLZA2016-03-09
2192301394823326K152593LATEX EXAMINATION GLOVE POWDER FREELYY2016-02-25
2192301123155546K152222NITRILE BLUE POWDER FREE EXAMINATION GLOVES tested for use with Chemotheraphy DrugsLZC2016-04-21
2192302049692319K151836NITRILE POWDER FREE EXAMINATION GLOVES-PINK, NITRILE POWDER FREE EXAMINATION GLOVES-GREEN,NITRILE POWDER FREE EXAMINATION GLOVES-ORANGE, NITRILE POWDER FREE EXAMINATION GLOVES-BLACKLZA2015-10-21
2192301403668569K151824Powder 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 DrugsLZA2016-08-02
2192301879901317K151750Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Powder Free Nitrile Patient Examination Glove, White Colored, Non-SterileLZA2016-08-03
2192301006159923K151694Gammex PI Hybrid Surgical GlovesKGO2016-03-09
1488671909778430K151528Powder Free Nitrile (Black) Examination GlovesLZA2015-10-09
2192301809866520K142862POWDER FREE NITRILE EXAMINATION GLOVE, BLUE (Colored).LZA2015-01-16
2192301454132396K142858POWDER FREE NITRILE EXAMINATION GLOVE, WHITE (colored)LZA2015-02-09
2192301409114233K142283Non-Sterile, Powder Free Nitrile Examination Gloves (Blue, Black and White Color)LZA2015-01-16
1488671859500134K140890NITRILE POWDER FREE EXAMINATION GLOVES (WHITE/DAWN BLUE/DARK VIOLET BLUE (DVBU)/COBALT BLUE (CBLU)LZA2014-07-24
2192301859500134K140890NITRILE POWDER FREE EXAMINATION GLOVES (WHITE/DAWN BLUE/DARK VIOLET BLUE (DVBU)/COBALT BLUE (CBLU)LZA2014-07-24
2192301486930396K140610NITRILE POWDER FREE EXAMINATION GLOVE - AQUA BLUE (ABLU) / VIOLET BLUE (VBLU) / DARK BLUE (DKBU)LZA2014-06-20
2192301663837467K133949POWDER FREE NITRILE PATIENT EXAMINATION GLOVE,BLUE AND ORANGE COLORED,NON-STERILE TESTED FOR USE WITH CHEMOTHERAPY DRUGSLZA2014-04-08
2192301127680114K133699POWDER FREE GREEN, BLUE AND BROWN POLYCHLOROPRENE EXAMINATION GLOVESLZA2014-07-18
2192301579467461K132221POWDER-FREE VINYL PATIENT EXAMINATION GLOVESLYZ2014-01-31
2192301309650840K131832POWDER-FREE VINYL PATIENT EXAMINATION GLOVESLYZ2014-01-07
2192301713148091K121594COLORED POWDER FREE LATEX EXAMINATION GLOVE (WHITE AND BLUE)LYY2012-10-25
2192301118251098K120692LATEX EXAMINATION GLOVES (POWDER FREE)LYY2012-05-14
2192301050235627K111139DERMA PRENE ISOTOUCH GREEN STERILE POWDER-FREE POLYISOPRENE SURGICAL GOVES, TESTED FOR UKGO2011-09-02
2192301739852620K110960ROYAL IMPERIAL NITRILE EXAMINATION GLOVES TEXTURED POWDER-FREELZA2011-07-14
2192301637874518K110758NITRILE POWDER FREE EXAMINATION GLOVESLZA2011-08-12
2192301176844525K110297POWDER FREE NITRILE (BLACK) EXAMINATION GLOVESLZA2011-06-15
2192301565964755K103714ENCORE ACCLAIM STERILE POWDER-FREE LATEX SURGICAL GLOVES, TESTED FOR USE WITH CHEMOTHERAKGO2011-07-07
2192301416819156K102790POWDER FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE COLORED NON-STERILE (LOW DERAMATITIS POTENTIAL AND CHEMOTHERAPY DRUGLZC2010-11-29
2192301742304274K102096POWDER FREE NITRILE EXAMINATION GLOVES, BLUELZA2010-10-04
2192302054066835K102074POWDER FREE NITRILE EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS, BLUE (SG)LZA2010-11-02
2192301011648485K101799POWDER FREE LATEX EXAMINATION GLOVES BLUE (COLORED), NON-STERILE, WITH PROTEIN LABELING CLAIM OF 50UG PER DM2 OF GLOVELYY2010-09-03
2192301258797374K100694COLORED POWDER FREE AND POLYMER COATED EXAMINATION GLOVE (BLUE, BLACK AND PINK) WITH A PROTEIN CLAIM OF LESS THANLYY2010-06-25
2192301872591262K100139SAFE LIFE N95 RESPIRATOR AND SURGICAL MASK, MODELS B130 AND B150MSH2010-05-04
2192301083465633K093696SR GLOVE, NU GLOVE, HIGHSTRESS MODEL 801, MODEL 802, MODEL 803LZA2010-02-12
2192301845173189K093523MICRO-TOUCH NITRILELZA2010-03-04
2192301309857961K092681POWDERED LATEX EXAMINATION GLOVES, NON-STERILELYY2010-02-23
2192301517407408K092327MICRO-TOUCH NITRA FREELZA2009-09-21
2192301741036608K091652NITRILE POWDER FRE EXAMINATION GLOVES (BLUE) TESTED FOR USE WITH CHEMOTHREAPY DRUGSLZA2009-09-04
2192301993154185K091431POWDER-FREE, YELLOW VINYL PATIENT EXAMINATION GLOVESLYZ2009-07-08
2192301615194212K090327POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVES, STERILE, WITH PROTEIN LABELING CLAIM OF 50 UG PER DM2 OF GLOVELYY2009-04-03
2192301979154865K083624POWDER FREE NITRILE (BLUE AND WHITE) EXAMINATION GLOVESLZA2009-02-10
2192301737801068K082457MICRO-TOUCH NITRATEX STERILE NITRILE POWDER-FREE BLUE EXAMINATION GLOVES (CHEMOTHERAPY USE)LZA2008-11-10
2192301533591443K081592POWDER FREE NITRILE (BLUE AND WHITE) EXAMINATION GLOVESLZA2008-12-03
2192301840702835K080937POWDER FREE NITRILE EXAMINATION GLOVE, ORANGELZA2008-05-23
2192301822206876K080536MICRO-TOUCH NITRAFREELZA2008-06-19
2192301297193542K071746DERMA PRENE PI OR ISOTOUCH GREEN STERILE POWDER-FREE SYNTHETIC POLYISOPRENE SURGICAL GLOVESKGO2007-12-13
2192301288841334K070076POWDER FREE VINYL PATINET EXAMINATION GLOVES, CLEAR (NON-COLORED)LYZ2007-02-22
2192301150724052K063627POWDER FREE NITRILE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS (BLUE)LZA2007-03-20
2192301488336969K062917STERILE AND NON-STERILE POWDER-FREE LATEX PATIENT EXAMINATION GLOVE, WITH EXTRACTABLE PROTEIN CONTENT LABELING CLAIM (50LYY2006-11-02
2192301128086285K061553NON-STERILE, POWDER-FREE BLACK NITRILE EXAMINATION GLOVESLZA2006-07-17
2192301400009335K060775POWDER-FREE LATEX PATIENT EXAMINATION GLOVE,WITH EXTRACTABLE PROTEIN CONTENT LABELLING CLAIM (50 MICROGRAM PER GRAM OFLYY2006-05-16
2192301094947148K051793ENCORE STERILE POWDER-FREE LATEX SURGICAL GLOVE WITH PROPRIETARY COATING (CONTAINING GLYCERINE)KGO2005-08-17

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LZA692023-08-28
LYY312021-08-20
KGO232023-10-20
LZC82019-10-23
LYZ42014-01-31
MSH12010-05-04

PMN#

GUDID#

80 records. Showing 1-40. Next