FDA.reportPublic FDA data

Don Cronk

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
96104063002806370Don Cronk1N2026-01-012301 Robb Drive Reno NV US 89503
30031996373003199637Don Cronk1N2026-01-012301 Robb Drive Reno NV US 89503
30247067523024706752Don Cronk1N2026-01-012301 Robb Drive Reno NV US 89523
30055410293005541029Don Cronk1N2020-04-252301 Robb Dr Reno NV US 89523

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2320111854826294K993876POWDER-FREE NITRILE EXAMINATION GLOVES WITH ALOE VERALZA2000-02-07
2320111332548607K993857THE ORIGINAL PERRY, STYLE 42 WHITE LATEX POWDERED SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (60 MICROGRAMS ORKGO2000-01-31
2320111834108741K992953SURGEONS GLOVE, BROWN LATEX POLYMER COATED, POWDER FREE WITH PROTEIN LABEL CLAIMKGO1999-10-29
2320111680753861K991422POWDER-FREE NITRILE EXAMINATION GLOVE (TESTED FOR USE WITH CHEMOTHERAPY DRUGS)LZA2000-05-03
2320111610325152K990882LAGLOVE BRAND COLORED NITRILE EXAMINATION GLOVES (POWDER FREE)LZA1999-05-21
2320111929655961K990013EVERGREEN NON-STERILE POWDER-FREE, COLORED NITRILE EXAMINATION GLOVESLZA1999-03-23
2320111177685800K984558DERMA PRENE POWDER-FREE SYNTHETIC SURGICAL GLOVES (CHEMOTHERAPY USE)KGO1999-02-26
2320111396960487K983489ENCORE MARK IV POWDER FREE POLYMER COATED LATEX SURGICAL GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LE)KGO1998-12-14
2320111617858827K983145TEXTURED POWDER-FREE LATEX EXAM GLOVES WITH ALOE VERA AND PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)LYY1999-01-26
2320111514528081K982872TG MEDICAL POWDER-FREE LATEX EXAMINATION GLOVE PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS)LYY1998-10-15
2320111718438119K982453NON-STERILE E.P. LATEX EXAMINATION GLOVELYY1998-11-30
2189251545480849K981064POWDERFREE COLORED AND FLAVORED CHLOROPRENE PATIENT EXAMINATION GLOVESLZA1998-11-05
2320111545480849K981064POWDERFREE COLORED AND FLAVORED CHLOROPRENE PATIENT EXAMINATION GLOVESLZA1998-11-05
2320111795394876K974424COMFORT RUBBER GLOVES INDUSTRIES SDN BHDLYY1998-04-23
2320111410569568K973778POLYMER COATED POWDER-FREE LATEX EXAMINATION GLOVESLYY1997-12-11
2320111303240213K972621PROFEEL POWDER FREE SURGICAL GLOVES (PROTEIN CONTENT LABELING)KGO1997-10-24
2320111699877195K970794LATEX PATIENT EXAMINATION (POWDERFREE GLOVE)LYY1997-05-06
2320111939242901K964148PATIENT EXAMINATION GLOVES; CHLORINATED POWDERFREE NITRILE EXAMINATION GLOVESLZA1997-02-07
2320111808530077K962188COMFIT POWDER FREE BLUE EXAMINATION GLOVES (HYPOALLERGENIC, LOW PROTEIN)LYY1996-07-26
2320111867674799K955029POWDER-FREE LATES EXAM GLOVES WITH PROTEIN CLAIMLYY1996-01-23
2320111056056547K953590COMFITLYY1996-06-27
2320111522024929K953213COMFIT (POWDER FREE EXAMINATION GLOVES (HYPOALLERGENIC, LOW PROTEIN, BEADED)LYY1996-10-11
2320111424921872K952051SCINITREX (POWDER FREE NITRILE EXAMINATION GLOVES)LZA1995-12-15
2320111556366378K930602LATEX EXAMINATION GLOVES, POWDER FREELYY1993-09-29
2320111634480820K904769SENSITOUCHKGO1991-01-28
95081796888646K231902GAMMEX 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
2320111201759637K213289Gammex® PI Plus Glove-in-Glove™ System Tested For Use with Chemotherapy DrugsKGO2023-05-26
3091171935170480K210724ENCORE 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
3091171127270788K210656ENCORE 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
95081917206689K210401Microflex 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
3091171001317762K202765ENCORE Latex Textured Surgical Gloves, Powder Free with Protein Content Labeling Claim (50 micrograms or less) and Tested for use with Chemotherapy drugsKGO2021-05-27
2320111370681405K162923NITRILE 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
2320111888531412K160974Gammex Cut-Resistant Glove LinerKGO2016-10-28
2320111394823326K152593LATEX EXAMINATION GLOVE POWDER FREELYY2016-02-25
2320112049692319K151836NITRILE 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
2189251006159923K151694Gammex PI Hybrid Surgical GlovesKGO2016-03-09
2320111006159923K151694Gammex PI Hybrid Surgical GlovesKGO2016-03-09
2320111454132396K142858POWDER FREE NITRILE EXAMINATION GLOVE, WHITE (colored)LZA2015-02-09
2320111814280767K141982DERMAGRIP POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVES, NON-STERILE, TESTED FOR USE WITH CHEMOTHERAPY DRUGSLZC2015-02-05
2320111859500134K140890NITRILE POWDER FREE EXAMINATION GLOVES (WHITE/DAWN BLUE/DARK VIOLET BLUE (DVBU)/COBALT BLUE (CBLU)LZA2014-07-24
2320111486930396K140610NITRILE POWDER FREE EXAMINATION GLOVE - AQUA BLUE (ABLU) / VIOLET BLUE (VBLU) / DARK BLUE (DKBU)LZA2014-06-20
2320111663837467K133949POWDER FREE NITRILE PATIENT EXAMINATION GLOVE,BLUE AND ORANGE COLORED,NON-STERILE TESTED FOR USE WITH CHEMOTHERAPY DRUGSLZA2014-04-08
2320111127680114K133699POWDER FREE GREEN, BLUE AND BROWN POLYCHLOROPRENE EXAMINATION GLOVESLZA2014-07-18
2320111948103239K133689POWDER FREE POLYCHLOROPRENE LIGHT WIEGHT EXAMINATIONGLOVES- GREEN,BLUE AND PINKLZA2014-07-03
2320111579467461K132221POWDER-FREE VINYL PATIENT EXAMINATION GLOVESLYZ2014-01-31
2320111730887884K123819MULTIPLE NAMELYY2013-03-05
2320111050235627K111139DERMA PRENE ISOTOUCH GREEN STERILE POWDER-FREE POLYISOPRENE SURGICAL GOVES, TESTED FOR UKGO2011-09-02
2320111637874518K110758NITRILE POWDER FREE EXAMINATION GLOVESLZA2011-08-12
2320111176844525K110297POWDER FREE NITRILE (BLACK) EXAMINATION GLOVESLZA2011-06-15
2320111565964755K103714ENCORE ACCLAIM STERILE POWDER-FREE LATEX SURGICAL GLOVES, TESTED FOR USE WITH CHEMOTHERAKGO2011-07-07
2320111416819156K102790POWDER FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE COLORED NON-STERILE (LOW DERAMATITIS POTENTIAL AND CHEMOTHERAPY DRUGLZC2010-11-29
2320112054066835K102074POWDER FREE NITRILE EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS, BLUE (SG)LZA2010-11-02
2320111011648485K101799POWDER FREE LATEX EXAMINATION GLOVES BLUE (COLORED), NON-STERILE, WITH PROTEIN LABELING CLAIM OF 50UG PER DM2 OF GLOVELYY2010-09-03
2320111258797374K100694COLORED POWDER FREE AND POLYMER COATED EXAMINATION GLOVE (BLUE, BLACK AND PINK) WITH A PROTEIN CLAIM OF LESS THANLYY2010-06-25
2320111872591262K100139SAFE LIFE N95 RESPIRATOR AND SURGICAL MASK, MODELS B130 AND B150MSH2010-05-04
2320111083465633K093696SR GLOVE, NU GLOVE, HIGHSTRESS MODEL 801, MODEL 802, MODEL 803LZA2010-02-12
2320111845173189K093523MICRO-TOUCH NITRILELZA2010-03-04
2320111517407408K092327MICRO-TOUCH NITRA FREELZA2009-09-21
2320111741036608K091652NITRILE POWDER FRE EXAMINATION GLOVES (BLUE) TESTED FOR USE WITH CHEMOTHREAPY DRUGSLZA2009-09-04
2320111993154185K091431POWDER-FREE, YELLOW VINYL PATIENT EXAMINATION GLOVESLYZ2009-07-08
2320111615194212K090327POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVES, STERILE, WITH PROTEIN LABELING CLAIM OF 50 UG PER DM2 OF GLOVELYY2009-04-03
2320111979154865K083624POWDER FREE NITRILE (BLUE AND WHITE) EXAMINATION GLOVESLZA2009-02-10
2320111737801068K082457MICRO-TOUCH NITRATEX STERILE NITRILE POWDER-FREE BLUE EXAMINATION GLOVES (CHEMOTHERAPY USE)LZA2008-11-10
2320111840702835K080937POWDER FREE NITRILE EXAMINATION GLOVE, ORANGELZA2008-05-23
2320111297193542K071746DERMA PRENE PI OR ISOTOUCH GREEN STERILE POWDER-FREE SYNTHETIC POLYISOPRENE SURGICAL GLOVESKGO2007-12-13
2320111228959483K071119POWDER FREE NITRILE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS (BLUE, WHITE)LZA2007-07-24
2320111150724052K063627POWDER FREE NITRILE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS (BLUE)LZA2007-03-20
2320111488336969K062917STERILE AND NON-STERILE POWDER-FREE LATEX PATIENT EXAMINATION GLOVE, WITH EXTRACTABLE PROTEIN CONTENT LABELING CLAIM (50LYY2006-11-02
2320111143895146K062764POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, WHITE (NON-COLORED) AND BLUE COLOREDLZC2007-02-27
2320111128086285K061553NON-STERILE, POWDER-FREE BLACK NITRILE EXAMINATION GLOVESLZA2006-07-17
2320111516162060K060786SYNTHETIC (YELLOW) VINYL PATIENT EXAMINATION GLOVE-POWDER FREELYZ2006-05-08
2320111400009335K060775POWDER-FREE LATEX PATIENT EXAMINATION GLOVE,WITH EXTRACTABLE PROTEIN CONTENT LABELLING CLAIM (50 MICROGRAM PER GRAM OFLYY2006-05-16
2320111825465161K060402BRIGHTWAY BRAND NITRILE EXAMINATION GLOVE (POWDER FREE, BLACK COLOUR)LZA2006-06-09
2320111094947148K051793ENCORE STERILE POWDER-FREE LATEX SURGICAL GLOVE WITH PROPRIETARY COATING (CONTAINING GLYCERINE)KGO2005-08-17
2320111417176397K051777NITRILE POWDER FREE EXAMINATION GLOVES (BLUE)LZA2005-08-12
2320111181420291K050214NITRILE POWDER FREE EXAMINATION GLOVES (WHITE)LZA2005-03-16
2320111010425407K041913POWDERFREE COLORED AND FLAVORED CHLOREPRENE PATIENT EXAMINATION GLOVES TESTED FOR CHEMO USELZA2004-12-01
2320111480713303K040702SYNTHETIC (YELLOW) VINYL PATIENT EXAMINATION GLOVES - POWDER FREELYZ2004-04-27
2320111188906715K040607MODIFICATION TO POWDERFREE COLORED AND FLAVORED CHLOROPRENE PATIENT EXAMINATION GLOVESLZA2004-04-22
2189251545150356K032374POWDER-FREE NITRILE PATIENT CHEMOTHERAPY EXAMINATION GLOVE, BLUE COLOREDLZC2003-10-22
2320111545150356K032374POWDER-FREE NITRILE PATIENT CHEMOTHERAPY EXAMINATION GLOVE, BLUE COLOREDLZC2003-10-22
2320111529099776K031580NON-STERILE, POWDER-FREE, BLUE COLOR NITRILE EXAMINATION GLOVELZA2003-07-25
2320111433060401K023153MICRO-TOUCH NEXT STEP POWDER FREE MEDICAL EXAMINATION GLOVES WITH ALOE AND GLYCEROLLYY2002-11-13
2320111487584893K022904DERMAGRIP-N/MULTIPLE/WRP ASIA PACIFIC SDN BHD POWDER FREE NITRILE EXAMINATION GLOVES, NON-STERILELZA2002-10-03
2320111817270736K022814MULTIPLE NITRILE EXAMINATION GLOVES (POWDERED)LZA2003-02-19
2320111862932468K020493SYNTEX POWDER-FREE NITRILE EXAMINATION GLOVELZA2002-02-26
2320111602406383K010097POWDER-FREE NITRILE EXAMINATION GLOVES WITH ALOE VERA, GREEN (TESTED FOR USE WITH CHEMOTHERAPY DRUGS)LZA2001-03-30
2320111611231171K003985POWDERFREE NITRILE PATIENT EXMINATION GLOVELZA2001-02-09
2320111801745781K000295ENCORE MICROPTIC POWDER FREE LATEX SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)KGO2000-02-16
3091171801745781K000295ENCORE MICROPTIC POWDER FREE LATEX SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)KGO2000-02-16
3091171006159923
3091171050235627
3091171094947148
3091171129242051
3091171149387991
3091171156483364
3091171177685800
3091171295679698
3091171297193542
3091171303240213
3091171332548607
3091171396960487
3091171487912892
3091171565964755
3091171614915310
3091171634480820
3091171796888646
3091171834108741
3091171888531412
3091171937960900
3091172015571590

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LZA412021-06-13
KGO202023-10-20
LYY192016-02-25
LZC52015-02-05
LYZ42014-01-31
MSH12010-05-04