FDA.reportPublic FDA data

HARTALEGA SDN BHD

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
80406143002807146HARTALEGA SDN BHD1N2026-01-01No 7, Kawasan Perusahaan Suria Bestari Jaya Selangor MY 45600

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
416711933737248K993760POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM OF 200 MICROGRAMS OR LESSLYY2000-05-15
416712060760612K993725GREEN CHLORINATED POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM OF 50 MICROGRAMS OR LESSLYY1999-11-23
416711031976279K993722BLUE CHLORINATED POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM OF 50 MICROGRAMS OR LESS.LYY1999-11-23
416711187252137K991616CHLORINATED POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)LYY1999-07-14
416711497924664K990283BLUE POWDER-FREE NITRILE EXAMINATION GLOVESLZA1999-03-09
416711439225729K980572POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (GREEN)LYY1998-03-13
416711436634978K980318POWDER-FREE LATEX EXAMINATION GLOVES (BLUE)LYY1998-03-11
416711556816756K973871LOW POWDER POLYMER LATEX EXAMINATION GLOVES (WITH PROTEIN LABELING CLAIM)LYY1997-12-11
416711661310821K973778POLYMER COATED POWDER-FREE LATEX EXAMINATION GLOVESLYY1997-12-11
416711802437300K964148PATIENT EXAMINATION GLOVES; CHLORINATED POWDERFREE NITRILE EXAMINATION GLOVESLZA1997-02-07
416711714436146K963804PATIENT EXAMINATION GLOVES : NITRILE EXAMINATION GLOVESLZA1997-02-10
416711212702631K954416POLYMER COATED POWDER-FREE LATEX EXAMINATION GLOVESLYY1996-10-11
416711709781451K954415PATIENT EXAMINATION GLOVES WITH PROTEIN LABELING CLAIMLYY1996-03-12
416711404631133K954221POLYMER COATED CHLORINATED POWDER-FREE LATEX EXAMINATION GLOVESLYY1996-05-03
416711096138304K945885PATIENT EXAMINATION GLOVESLYY1995-03-23
416711912167163K892104PATIENT EXAMINATION GLOVES (LATEX)LYY1989-05-31
416711113127575K201748Latex Powder Free Surgical Glove with Protein Labelling Claim of 50 Microgram or Less per Gram of Glove and Tested for use with Chemotherapy DrugsKGO2020-10-02
416711357222522K201531Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue)LZA2020-08-05
416711128990276K200897Polyisoprene Powder Free Surgical Underglove for Use with Chemotherapy Drugs (Blue), Polyisoprene Powder Free Surgical Glove for Use with Chemotherapy Drugs (Natural)KGO2020-06-01
416711694084804K192315Medline Green Ambidextrous Power-Free Nitrile Examination Gloves with Colloidal Oatmeal USP (Tested for Use with Chemotherapy Drugs)LZA2020-01-10
416711643348920K190454Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Blue), Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Blue) - Extended CuffLZA2019-09-26
416711655724459K180786Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs Aqua Blue (ABLU), Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs Violet Blue (VBLU) - Extended CuffLZA2018-11-02
416711755152506K180696Medline Green Ambidextrous Powder-Free Nitrile Examination Gloves with Colloidal Oatmeal (Tested for use with Chemotherapy Drugs)LZA2018-04-30
416711745824934K180646Halyard Lavender Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy DrugsLZC2018-06-27
416711063995676K180645Powder Free Examination Gloves with Colloidal Oatmeal USP and Tested for Use with Chemotherapy Drugs - (Lemon Green)LZA2018-11-16
416711581378659K180644Nitrile Powder Free Examination Gloves with Colloidal Oatmeal - Lemon GreenLZA2018-08-10
416711980675911K180505Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP with Low-Dermatitis Potential Claim and Tested For Use with Chemotherapy Drugs (White)LZA2018-06-14
416711078775689K173509Biodegradable Nitrile Powder Free Examination Glove (Blue)LZA2018-08-17
416711177719431K173137Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Pink)LZA2017-12-12
416711807696886K172442Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs (Blue)LZA2017-11-06
416711552398884K171874Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant and Tested for Use With Chemotherapy Drugs (Dawn Blue)LZA2017-10-12
416711425502686K170686Nitrile Examination Gloves, Powder Free [Purple] Tested for Use with Chemotherapy DrugsLZA2017-07-14
416711940021855K170152POLYCHLOROPRENE POWDER FREE SURGICAL GLOVE (GREEN)KGO2017-05-05
416712040186879K162982Medline Nitrile Powder-Free Examination Glove with Colloidal Oatmeal USP (Tested for Use with Chemotherapy Drugs)LZA2017-02-27
416711323341205K162924Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs (White); Dark Violet Blue (DVBU); Dark Blue (DKBU)LZA2017-01-24
416711308985125K162819Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Tested for Use with Chemotherapy DrugsLZA2017-01-09
416711030109297K162818Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs (Blue)LZA2017-01-09
416711971662861K162491Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue)LZA2017-02-08
416712035652428K162294BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12”, POWDER FREE, [PURPLE] TESTED FOR USE WITH CHEMOTHERAPY DRUGSLZA2017-04-21
416712034711058K162186BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12”, POWDER FREE, [STERLING/GREY] WITH CHEMOTHERAPY CLAIMLZC2017-03-31
416711189394201K161215Brightway Brand Nitrile Examination Gloves, Powder Free, [Sterling/Grey] Tested For Use With Chemotherapy DrugsLZA2016-12-21
416711303734976K161008POLYISOPRENE POWDER FREE SURGICAL UNDERGLOVE, POLYISOPRENE POWDER FREE SURGICAL GLOVEKGO2016-07-28
416711832634606K161006Latex Powder Free Polymer Coated Examination Glove with Protein Labeling Claim of 50 Microgram or Less Per Gram of GloveLYY2016-08-04
416711960037549K160928Latex Polymer Coated Powder Free Surgical Glove with Protein Labeling Claim of 50 microgram or Less per Gram of Glove (Natural), Latex Polymer Coated Powder Free Surgical Glove with Protein Labeling Claim of 50 microgram or Less per Gram of Glove (Green)KGO2016-12-20
416711272657438K160562Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Tested for Use with Chemotherapy DrugsLZA2016-10-13
416711478646997K160560Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs (Blue)LZA2016-08-04
416712060549869K150593Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue)LZA2015-06-09
416711777059139K150103Nitrile Powder Free Examination Gloves (Orange) Tested For Use With Chemotherapy DrugsLZA2015-04-23
416711618861288K142805Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant Drug- Dark Violet Blue (DVBU)LZA2014-12-18
416711152945346K142588Nitrile Powder Free Examination Glove (Blue)LZA2014-12-18
416711722461134K142270LATEX POWDERED EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM OF 200 MICROGRAM OR LESS PER GRAM OF GLOVELYY2014-11-25
416711294066203K140050NITRILE POWDER FREE EXAMINATION GLOVE WITH COLLOIDAL OATMEAL USP SKIN PROTECTANT DRUG - DKBU /DARK BLUELZA2014-09-12
416711865508304K133956NITRILE POWDER FREE EXAMINATION GLOVE WITH COLLOIDAL OATMEAL USP SKIN PROTECTANT DRUG - WHITE / DAWN BLUE / LEMON GREENLZA2014-05-28
416711478403488K133953LATEX POWDER FREE EXAMINATION GLOVES WITH COLLOIDAL OATMEAL USP SKIN PROTECTANT DRUG WITH PROTEIN LABELING CLAIM OF 50 MLYY2014-05-28
416711800635874K132006STERILE NITRILE POWDER FREE EXAMINATION GLOVE(VBLU), STERLE NITRILE POWDER FREE EXAMINATION GLOVE(ABLU)LZA2013-11-07
416711841626286K130473NITRILE POWDER FREE EXAMINATION GLOVE (ABLU)LZA2013-07-05
416711367268776K123368LATEX POWDER FREE EXAMINATION GLOVES WITH COLLOIDAL OATMEAL USP SKIN PROTECTANTLYY2013-05-07
416711899953450K122696POWDER-FREE NITRILE EXAMINATION GLOVES (COOL BLUE)LZA2013-01-31
416711041455185K120336NITRILE POWDER FREE EXAMINATION GLOVES (VIO) TESTED FOR USE WITH CHENITRILE POWDER FREE EXAMINATION (ABLU) TESTED FOR ULZC2012-06-25
416711814009132K112976NITRILE POWDER FREE EXAMINATION GLOVES (WHITE) WITH COLLOIDAL OATMLZA2012-02-02
416711610342780K111589POWDER FREE NITRILE PATIENT EXAMINATION GLOVE WITH COLLOIDAL OATMEAL USP A SKIN PROTECTANT DRUGLZA2011-08-23
416711328700811K110921NITRILE POWDER-FREE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGSLZA2011-04-15
416712003111678K110758NITRILE POWDER FREE EXAMINATION GLOVESLZA2011-08-12
416712053114471K091652NITRILE POWDER FRE EXAMINATION GLOVES (BLUE) TESTED FOR USE WITH CHEMOTHREAPY DRUGSLZA2009-09-04
416711587272136K090568MEDLINE NITRILE EXAM GLOVES W/ALOE -GREENLZA2009-10-02
416711051168681K081594MEDLINE POWDER-FREE NITRILE EXAMINATION GLOVE WITH ALOELZA2008-10-17
416711280487182K081260KIMBERLY-CLARK *LAVENDER* NITRILE POWER-FREE EXAM GLOVESLZA2008-07-09
416711131169222K081089KIMBERLY-CLARK STERLING NITRILE & NITRILE-XTRA POWDER-FREE EXAM GLOVES WITH CHEMOTHERAPY DRUG USE CLAIMLZC2008-07-14
416711119565571K071910NITRILE POWDER FREE EXAMINATION GLOVES (BLUE), NITRILE POWDER FREE EXAMINATION GLOVES (PINK)LZA2007-09-06
416711148169921K070760POWDER FREE CHLORINATED LATEX PATIENT EXAMINATION GLOVELYY2007-06-07
416711923198540K063046NITRILE POWDER FREE EXAMINATION GLOVES (GREEN)LZA2006-11-17
416711226174152K052583BLUE POWDER FREE NITRILE EXAMINATION GLOVESLZA2006-06-14
416711575687888K052177POWDER FREE STERILE LATEX SURGICAL GLOVESKGO2005-12-09
416711805221954K051778NITRILE POWDERED EXAMINATION GLOVES (BLUE)LZA2005-07-26
416711434716728K051777NITRILE POWDER FREE EXAMINATION GLOVES (BLUE)LZA2005-08-12
416712034135955K051378POWDER-FREE BLUE NITRILE EXAMINATION GLOVES (TESTED FOR USE WITH CHEMOTHERAPY DRUGS)LZA2005-08-03
416711172622630K050277CHLORINATED POWDER FREE LATEX EXAMINATION GLOVES (YELLOW)LYY2005-06-07
416711527116318K050215NITRILE POWDERED EXAMINATION GLOVES (WHITE)LZA2005-03-11
416711758536533K050214NITRILE POWDER FREE EXAMINATION GLOVES (WHITE)LZA2005-03-16
416711499593577K002593POWDER FREE STERILE LATEX SURGICAL GLOVES, CONTAINS 50 MICROGRAM OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GRAMKGO2000-11-29
416711732909617K001959POWDERED STERILE LATEX SURGICAL GLOVE, WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS)KGO2000-07-26

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LZA502020-08-05
LYY192016-08-04
KGO82020-10-02
LZC42018-06-27

PMN#

42 records. Showing 1-40. Next