FDA.reportPublic FDA data

WRP ASIA PACIFIC SDN. BHD.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
80410053002808507WRP ASIA PACIFIC SDN. BHD.1N2026-01-01LOT 1, JALAN 3 KAWASAN PERUSAHAAN BANDAR BARU SALAK TINGGI, SEPANG Selangor MY 43900

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
418641670273073K993313COMFIT POWDER FREE BLUE NITRILE EXAMINATION GLOVE, STERILELZA1999-11-23
418641391732693K993311COMFIT POWDER FREE NITRILE EXAMINATION GLOVE, STERILELZA1999-11-19
418641345133271K982600PROFEEL SYNTHETIC COPOLYMER SURGICAL GLOVES (POWDERED)KGO1999-03-12
418641429797465K982600PROFEEL SYNTHETIC COPOLYMER SURGICAL GLOVES (POWDERED)KGO1999-03-12
418642039191023K982600PROFEEL SYNTHETIC COPOLYMER SURGICAL GLOVES (POWDERED)KGO1999-03-12
418641646481207K972621PROFEEL POWDER FREE SURGICAL GLOVES (PROTEIN CONTENT LABELING)KGO1997-10-24
418641968328636K972616ONCOLOGY PLUS POWDER FREE LATEX EXAMINATION GLOVES (PROTEIN CONTENT LABELING)LYY1999-01-27
418641084431803K972615CHEMO PLUS POWDER FREE BLUE LATEX EXAMINATION GLOVES (PROTEIN CONTENT LABELING)LYY1999-01-26
418641400007958K962189COMFIT POWDER FREE GREEN EXAMINATION GLOVES (HYPOALLERGENIC, LOW PROTEIN)LYY1996-07-26
418641127729913K962188COMFIT POWDER FREE BLUE EXAMINATION GLOVES (HYPOALLERGENIC, LOW PROTEIN)LYY1996-07-26
418641248381092K960416COMFIT MICROPTICKGO1996-04-26
418641313647702K960407COMFIT ORTHOPEDICKGO1996-04-26
418641876418401K960178COMFIT BROWN, BEADED SURGEON'S GLOVES (POWDERED, HYPOALLERGENIC)KGO1996-05-06
418641633398530K953213COMFIT (POWDER FREE EXAMINATION GLOVES (HYPOALLERGENIC, LOW PROTEIN, BEADED)LYY1996-10-11
418641997491277K952155SCINITREX BLUE POWDERED NITRILE EXAMINATION GLOVESLZA1995-12-11
418641131649156K952154SCINITREX POWER FREE BLUE NITRILE EXAMINATION GLOVESLZA1995-12-15
418641575995866K952052SCINITREX (POWDERED NITRILE EXAMINATION GLOVESD)LZA1995-10-30
418641282161623K952051SCINITREX (POWDER FREE NITRILE EXAMINATION GLOVES)LZA1995-12-15
418641302962194K951938SCINITREX (POWDER FREE GREEN NITRILE EXAMINATION GLOVESLZA1995-12-15
418641515771020K951921SCINITREX (GREEN POWDERED NITRILE EXAMINATION GLOVES)LZA1995-10-30
418642004114350K951668SCIPOTEX/POWDER FREE EXAMINATION GLOVESLYY1995-05-17
418641423081535K951667COMFIT/GREEN POWDERED EXAMINATION GLOVESLYY1995-05-17
418641402442357K951662COMFIT/BEADED SURGEON'S GLOVEKGO1995-05-17
418641368104071K951661PROFEELKGO1995-05-17
418641411772513K951473ULTIMAXKGO1995-07-17
418641765046336K951468COMFITLYY1995-04-28
418641475731151K951467ULTIMAXLYY1995-04-28
418641386666458K951456SCIPOTEX (BLUE)LYY1995-04-28
418641846577451K951455SCIPOTEX (PINK)LYY1995-04-28
418641934395147K951171SCIPOTEXLYY1995-04-13
418641497818448K951137COMFIT FPOWDER FREE EXAMINATION GLOVERS (HYPOALLERGENIC)LYY1995-04-13
418641153532317K944141COMFIT (STERILE)LYY1994-10-13
418641112412743K944140COMFITLYY1994-12-07
418641794381691K943869ULTIMAX (GREEN POWDER FREE EXAMINATION)LYY1995-02-21
418642040923182K943868SCIPOTEXLYY1995-02-03
418641414688044K943601COMFIT (PINK)LYY1995-05-17
418641155885743K943566ULTIMAX POWDER FREE SURGICAL GLOVES (UNBEADED)KGO1995-02-03
418641182475405K943563COMFIT BLUE POWDER FREE EXAMINATION GLOVESLYY1995-03-07
418641588330032K943451ULTIMAX POWDER FREE EXAMINATION GLOVESLYY1995-02-24
418641130716025K943255SCIPOTEX POWDER FREE SURGICAL GLOVES (UNBEADED)KGO1995-03-07
418641430870822K943254SCIPOTEX POWDER FREE SURGICAL GLOVES (BEADED)KGO1995-03-07
418641711822462K942947COMFIT EXAMINATION GLOVES, POWDER FREE, HYPOALLERGENICLYY1994-11-30
418641235757641K942511SCIPOTEX POWDER FREE EXAM GLOVES (BEADED)LYY1995-02-03
418641143013384K942510SCIPOTEX POWDER FREE EXAM GLOVES (UNBEADED)LYY1994-08-05
418641096235056K941969ENDOPLUSBTR1994-06-22
418641148740745K936295COMFIT BLUE POWERED EXAMINATION GLOVES (HYPOALLERGENIC)LYY1995-02-24
418641654924004K936268COMFIT BLUE POWDERED EXAMINATION GLOVESLYY1994-12-07
418641845750944K936267COMFIT PINK POWDERED EXAMINATION GLOVESLYY1994-06-22
418641403077542K936266COMFIT PINK POWDERED EXAMINATION GLOVES (HYPOALLERGENIC)LYY1995-04-13
418641437530374K936265COMFIT GREEN POWDERED EXAMINATION GLOVESLYY1994-06-22
418641190765729K935866COMFIT POWERED EXAMINATION GLOVES(BEADED, HYPOALLERG)LYY1994-05-18
418641311986233K935864POWDERED EXAMINATION GLOVES (HYPOALLERGENIC)LYY1994-05-09
418641572815678K935852COMFIT POWDER FREE EXAMINATION GLOVES (HYPOALLERGENIC)LYY1994-03-07
418641721112181K935464COMFITKGO1994-05-09
418641136746653K934813COMFIT BLUE POWDER FREE EXAMINATION GLOVELYY1994-01-07
418641592439190K934812COMFIT GREEN POWDER FREE EXAMINATION GLOVELYY1994-01-07
418641388641226K933263COMFITLYY1994-02-01
418641546511747K922551SOLACE POWDER FREE LATEX EXAMINATION GLOVESLYY1993-05-11
418641701396283K922515PROFEEL ANATOM SURG GLOVES (POWDER FREE/HYPOALLER)KGO1992-11-25
418641318465074K922513COMFIT STERILE LATEX EXAMINATION GLOVELYY1992-08-20
418641312773247K914824HYPOALLERGENIC SURGEON'S GLOVES - STERILEKGO1992-01-17
418641500890045K914824HYPOALLERGENIC SURGEON'S GLOVES - STERILEKGO1992-01-17
418641291368221K903777WRP FOLEYCATHEZL1990-12-13
418641841191527K903746COMFIT, PATIENT EXAMINATION GLOVESFMC1990-09-05
418641375859780K903446COMFIT SURGEON'S GLOVESKGO1990-10-01
418641105010651K232538DUAL COLOR NITRILE EXAMINATION GLOVES, POWDER FREE, NON-STERILE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS AND FENTANYLLZA2023-11-17
418641007360572K232079Natural Rubber Latex Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl (Green); Natural Rubber Latex (Strip&Coat)/(Strip&Pack) Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and FentanylKGO2024-03-28
418641058763297K230578Polyisoprene Surgical Glove (Unified Double Layer), Sterile, Tested for Use with Chemotherapy Drugs and FentanylKGO2023-08-31
418641290673913K222058Polyisoprene Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl ResistantKGO2022-10-22
418641709021206K211601Powder Free Latex Examination Glove, Non-SterileLYY2022-08-22
418641547887746K210330Powder Free Black Nitrile Examination Gloves, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl ResistantLZA2022-03-04
418641722087245K203030POWDER FREE NITRILE SURGICAL GLOVE, STERILE, TESTED FOR USE WITH CHEMOTHERAPY DRUGSKGO2021-06-11
418641352704861K192635Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Orange)LZA2020-01-17
418641643531261K161823Powder Free Nitrile Surgical Glove, Sterile, Tested for use with Chemotherapy DrugsKGO2017-01-23
418641240198476K161422DERMAGRIP POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVES, NON-STERILE, TESTED FOR USE WITH CHEMOTHERAPY DRUGSLZA2016-10-20
418641491896262K141982DERMAGRIP POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVES, NON-STERILE, TESTED FOR USE WITH CHEMOTHERAPY DRUGSLZC2015-02-05
418641189756048K133168DERMAGRIP POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVES, NON-STERILELZA2014-08-07
418641089683120K132484DERMAGRIP POWDER FREE BLACK NITRILE PATIENT EXAMINATION GLOVES, NON-STERILELZA2013-12-13
418641194201348K111807MEDLINE POWDER-FREE LATEX SURGICAL GLOVES, STERILE, W/ OR W/O ALOE VERA, WITH PROTEIN CONTENT LABELING CLAIM...KGO2011-08-18
418641098967409K110921NITRILE POWDER-FREE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGSLZA2011-04-15
418641408413165K083410POWDER FREE LATEX PATIENT EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS WITH A PROTEIN CONTENT LABEL CLAIMLZC2009-07-31
418641238683223K083409POWDER FREE BLUE LATEX PATIENT EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS WITH A PROTEIN CONTENT LABELLZC2009-07-29
418641219991152K083408POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGSLZC2009-07-31
418641600852487K083305POWDER FREE NITRILE EXAMINATION GLOVES, STERILE WITH CHEMOTHERAPY CLAIMLZC2009-06-18
418641734088362K070619POWDER FREE POLYMER COATED BROWN LATEX SURGICAL GLOVES, STERILE, COATED WITH ALOE VERA AND WITH PROTEIN CONTENT LABELINGKGO2007-06-27
418642041149043K040645DERMAGRIP-G, AND MULTIPLE CUSTOMERS TRADE NAME GREEN, ALOE VERA COATED, POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEILYY2004-04-28
418641356333160K040503ALOETOUCH POWDER FREE, POLYMER COATED POLYISOPRENE SURGICAL GLOVES, STERILE, COATED WITH ALOE VERA, NATURAL COLOURKGO2004-03-16
418641852110044K032942PROFEEL POWDER FREE, PLOYMER COATED POLYISOPRENE SURGICAL GLOVES, STERILEKGO2003-12-17
418641073168443K032647ALOETOUCH POWDER FREE NEOPRENE SURGICAL GLOVES, STERILE, TURQUOISE COLOUR AND COATED WITH ALOE VERAKGO2003-11-07
418641130968642K032464ALOETOUCH POWDER FREE LATEX SURGICAL GLOVES, STERILE, COATED WITH ALOE VERA AND WITH PROTEIN CONTENT LABELING CLAIM (50KGO2003-08-22
418641434176005K030157POWDER FREE LATEX EXAMINATION GLOVES, STERILE WITH PROTEIN CONTENT LABELING CLAIMLYY2003-02-19
418641940002566K024130POWDER FREE POLYMER COATED GREEN NEOPRENE SURGICAL GLOVES, STERILEKGO2002-12-30
418641961069052K023517DERMAGRIP-P POWDER FREE PINK NITRILE EXAMINATION GLOVES, NON-STERILELZA2002-12-02
418641634707462K023490DERMAGRIP-X POWDER FREE LATEX EXAMINATION GLOVES WITH SKIN-CARE INGREDIENTS (VITAMIN A, VITAMIN B, OC-LIPOIC ACID, EUCALLYY2003-01-16
418641557933007K022904DERMAGRIP-N/MULTIPLE/WRP ASIA PACIFIC SDN BHD POWDER FREE NITRILE EXAMINATION GLOVES, NON-STERILELZA2002-10-03
418641257250436K022444POWDER FREE GREEN NEOPRENE SURGICAL GLOVES, STERILE WITH ALOE VERAKGO2002-09-17
418642034537989K022442POWDER FREE GREEN LATEX SURGICAL GLOVES, STERILE WITH ALOE VERA AND PROTEIN CONTENT LABELING CLAIM (50 MICROGRAM LESS)KGO2002-09-05
418641016401186K021784PROFEEL POWDER FREE POLYMER COATED BROWN LATEX SURGICAL GLOVES, STERILE (PROTEIN LABELING CLAIM)KGO2002-07-24
418641571319312K020019POWDER FREE POLYMER COATED LATEX SURGICAL GLOVES, STERILE (PROTEIN LABELING CLAIM)KGO2002-01-23
418641612839673K012135POWDER FREE BROWN LATEX SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)KGO2001-08-01
418641295015332K012048POWDER FREE NEOPRENE EXAMINATION GLOVES, NON STERILELZA2001-08-16
418642070402182K011482DERMASAFE CHEMO PLUS POWDER FREE NEOPRENE EXAMINATION GLOVE (TESTED FOR USE WITH CHEMOTHERAPY DRUGS)LZA2001-07-09
418641111443410K010072POWDER FREE PURPLE NITRILE EXAMINATION GLOVES, NONSTERILELZA2001-01-26
418641804441655K003653STERILE POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVES, WITH PROTEIN LABELING CLAIM (50 MICROGRAM OR LESS)LYY2001-01-26
418641765100568K003019PROFEEL POWDER FREE POLYMER COATED NEOPRENE SURGICAL GLOVES STERILEKGO2000-11-03
418641613137084K002064COMFIT CHEMO PLUS POWDER FREE BLUE NITRILE EXAMINATION GLOVES, NON STERILE (TESTED FOR USE WITH CHEMOTHERAPY DRUG) LABELLZA2000-11-28
418641256947221K001613COMFIT CHEMO PLUS PLUS POWDER FREE NITRILE EXAMINATION GLOVES (TESTED FOR USE WITH CHEMOTHERAPY DRUGS)LZA2000-11-22
418641398405089K001280COMFIT POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVE, NON STERILE WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESLYY2000-05-15
418641910163417K000971PROFEEL POWDER FREE NITRILE SURGICAL GLOVE, STERILEKGO2000-04-14
418641804176814
418641691450880
418641726185112
418641807083228

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LYY422022-08-22
KGO372024-03-28
LZA222023-11-17
LZC52015-02-05
BTR11994-06-22
EZL11990-12-13
FMC11990-09-05

PMN#