FDA.reportPublic FDA data

KOSSAN INTERNATIONAL SDN BHD

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30095389213009538921KOSSAN INTERNATIONAL SDN BHD1N2026-01-01KOSSAN Tower, No. 6D, Persiaran Setia Dagang, Setia Alam, Seksye Shah Alam Selangor MY 40170

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1381631208871134K980916POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIMLYY1998-08-18
1381631385606544K925030SURGEON'S GLOVEKGO1993-07-13
1381631103493594K892086PATIENT EXAMINATION GLOVES (LATEX)LYY1989-05-04
1381631034595220K252549Non-sterile Powder Free Nitrile Examination Glove, Dual Color (White-Green), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Xylazine HCl, and Simulated Gastric Acid; Non-sterile Powder Free Nitrile Examination Glove, Dual Color (White-Blue), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Xylazine HCl, and Simulated Gastric AcidLZA2026-01-13
1381631563114688K241780Cardinal Health Nitrile Exam GlovesLZA2024-08-23
1381631077435213K232461Powder Free Nitrile Examination Glove, Pink Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Powder Free Nitrile Examination Glove, Orange Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Powder Free Nitrile Examination Glove, Blue Colored, Non-Sterile, Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Powder Free Nitrile Examination Glove, Black Colored, Non-Sterile, Low DermatitisLZA2023-11-14
1381631177005347K230573Powder Free Latex Patient Examination Glove, Black Colored, Non-sterile, with Protein Content labeling Claim (Contains 50 ug per dm2 of glove or less of Total Water Extractable Protein)LYY2023-06-13
1381631276584872K223375Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-sterile, Low Dermatitis Potential. Tested for Use with Chemotherapy Drugs and Fentanyl Citrate.LZA2023-03-15
1381631877059651K200960Medline Powder Free Examination Gloves (Tested for use with Chemotherapy Drugs)LZA2020-07-13
1381631331513521K190606Powder Free Nitrile Patient Examination Glove, Black Colored, Non-SterileLZA2019-05-28
1381631647363919K183287Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Powder Free Nitrile Patient Examination Glove, White Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Powder Free Nitrile Patient Examination Glove, Black Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl CitrateLZA2019-04-05
1381631063579751K181857Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Low Dermatitis Potential. Tested for Use with Chemotherapy Drugs and Fentanyl CitrateLZA2018-11-20
1381631208176085K172420Sterile Powder Free Nitrile Surgical Glove, White Colored. Tested for Use with Chemotherapy Drugs, with Non-Pyrogenic Labeling ClaimKGO2017-09-29
1381631436712412K170397Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Polymer Coated, Tested for Use with Chemotherapy Drugs; Powder Free Nitrile Patient Examination Glove, White Colored, Non-Sterile, Polymer Coated, Tested for Use with Chemotherapy DrugsLZA2017-07-10
1381631688832165K160467Sterile Powder Free Nitrile Examination Gloves, Blue Colored. Tested For Use with Chemotherapy Drugs, with Non-Pyrogenic Labeling ClaimLZA2016-08-02
1381631128455154K151824Powder 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
1381631070709409K151750Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Powder Free Nitrile Patient Examination Glove, White Colored, Non-SterileLZA2016-08-03
1381631118629606K143131Powder Free Nitrile Patient Examination Glove, Black Colored, Non-SterileLZA2015-02-12
1381631915066318K133949POWDER FREE NITRILE PATIENT EXAMINATION GLOVE,BLUE AND ORANGE COLORED,NON-STERILE TESTED FOR USE WITH CHEMOTHERAPY DRUGSLZA2014-04-08
1381631435864708K123819MULTIPLE NAMELYY2013-03-05
1381631028130107K123469POWDER FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE AND WHITE COLORED, NON-STERILELZA2013-02-19
1381631650088897K123026TEXTURED, BLUE, LATEX, POWDER FREE EXAMINATION GLVOES, WITH PROTEIN LABELING CLAIM (50UG/DM OR LESS OF WATER SOLUBLE PROLYY2012-11-16
1381631623877530K121464BLUE POWER FREE NITRILE EXAMINATION GLOVELZA2012-07-05
1381631254729083K120692LATEX EXAMINATION GLOVES (POWDER FREE)LYY2012-05-14
1381632000369788K112988POWDER FREE LATEX PATIENT EXAM GLOVE WITH PROTEIN LABELING CLAIM (50 MICROGRAMS PER DM SQUARED OR LESS OF WATER SOLUBLELYY2011-11-09
1381631033762879K112612POWDER FREE LATEX PATIENT EXAMINATION GLOVE, WITH PROTEIN CONTENT LABELING CLAIMLYY2012-01-18
1381631996357519K110921NITRILE POWDER-FREE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGSLZA2011-04-15
1381631074589064K103337MULTIPLE NAMELZA2011-02-25
1381631773889652K102790POWDER FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE COLORED NON-STERILE (LOW DERAMATITIS POTENTIAL AND CHEMOTHERAPY DRUGLZC2010-11-29
1381631432763254K093500POWDER FREE NITRILE EXAMINATION GLOVES, WHITE (NON-COLORED) OR BLUE (COLORED), NON-STERILELZC2010-01-19
1381631705224664K092327MICRO-TOUCH NITRA FREELZA2009-09-21
1381631938590083K090327POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVES, STERILE, WITH PROTEIN LABELING CLAIM OF 50 UG PER DM2 OF GLOVELYY2009-04-03
1381632039258986K090066POWDER FREE POLYMER COATED LATEX SURGICAL GLOVES, STERILE, WITH PROTEIN LABELING CLAIM OF 50 MICROGRAMS PER DM2 OF GLOVEKGO2009-05-15
1381631291354363K081260KIMBERLY-CLARK *LAVENDER* NITRILE POWER-FREE EXAM GLOVESLZA2008-07-09
1381631576313319K081089KIMBERLY-CLARK STERLING NITRILE & NITRILE-XTRA POWDER-FREE EXAM GLOVES WITH CHEMOTHERAPY DRUG USE CLAIMLZC2008-07-14
1381631169276238K062965CHLORINATED, POLYMER-COATED POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN LABELING CLAIMLYY2006-12-22
1381631539185305K062778STERILE POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE COLOREDLZA2006-10-27
1381631295223563K062764POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, WHITE (NON-COLORED) AND BLUE COLOREDLZC2007-02-27
1381631445790716K060771POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE,WHITE (NON-COLORED) AND BLUE COLOREDLZA2006-05-01
1381631423304550K051378POWDER-FREE BLUE NITRILE EXAMINATION GLOVES (TESTED FOR USE WITH CHEMOTHERAPY DRUGS)LZA2005-08-03
1381631465467516K032374POWDER-FREE NITRILE PATIENT CHEMOTHERAPY EXAMINATION GLOVE, BLUE COLOREDLZC2003-10-22
1381631334559158K031591POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, WHITE (NON-COLORED), BLUE AND GREEN COLOREDLZA2003-06-26
1381631817363649K010211STERILE NITRILE POWDER-FREE EXAMINATION GLOVESLZC2001-02-15
1381631606200542K001190POLYMER COATED, POWDER-FREE LATEX EXAMINATION GLOVE CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PELYY2000-05-23

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LZA242026-01-13
LYY112023-06-13
LZC62010-11-29
KGO32017-09-29

PMN#