PERUSAHAAN GETAH ASAS SDN. BHD.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30045533903004553390PERUSAHAAN GETAH ASAS SDN. BHD.1N2026-01-01LOT 1365, BATU 17 JALAN SUNGAI SEMBILANG JERAM Selangor MY 45800

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
114091588577390K982807POLYMER COATED, POWDER-FREE LATEX EXAMINATION GLOVELYY1998-09-30
114091586597288K982806CHLORINATED, POLYMER COATED, POWDER-FREE LATEX EXAMINATION GLOVELYY1998-09-30
114091426304484K980916POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIMLYY1998-08-18
114091957758559K190606Powder Free Nitrile Patient Examination Glove, Black Colored, Non-SterileLZA2019-05-28
114091148074827K183287Powder 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
114091555274541K151750Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Powder Free Nitrile Patient Examination Glove, White Colored, Non-SterileLZA2016-08-03
114091712550631K102790POWDER FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE COLORED NON-STERILE (LOW DERAMATITIS POTENTIAL AND CHEMOTHERAPY DRUGLZC2010-11-29
114092010362750K042805POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE COLORED NON-STERILELZC2004-12-16
114091282119742K032374POWDER-FREE NITRILE PATIENT CHEMOTHERAPY EXAMINATION GLOVE, BLUE COLOREDLZC2003-10-22
114091361385022K031591POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, WHITE (NON-COLORED), BLUE AND GREEN COLOREDLZA2003-06-26
114091665692400K031414POWDER-FREE LATEX PATIENT EXAMINATION GLOVE, WHITE (NON-COLORED), OR BLUE COLORED, WITH EXTRACTABLE PROTEIN CONTENT LABELYY2003-06-26
114091372956163K031021CHLORINATED, POLYMER COATED, POWDER-FREE LATEX EXAMINATION GLOVELYY2003-06-13
114091611721171K024184POWDER-FREE COATED NITRILE EXAMINATION GLOVE, BLUE COLOREDLZA2003-01-14
114091220973020K023262POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN LABELING CLAIM (200 MICROGRAM PER GRAM OF GLOVE OR LESS)LYY2002-10-28
114091190737405K011271POWDER-FREE LATEX EXAMINATION GLOVE, BLUE COLOREDLYY2001-05-08
114092065618244K001529POLYMER COATED, POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN LABELLING CLAIM, CONTAINS 50 MICROGRAMS OR LESS OF TOTALYY2000-06-12
114091006263237
114091046410039
114091148074827
114091254747248
114091271095869
114091330082749
114091349744963
114091420839962
114091464451996
114091511053768
114091555274541
114091630203135
114091715752291
114091802009800
114091812504867
114091901996852
114091956983258
114091957758559
114091965532728
114091995497355

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LYY82003-06-26
LZA52019-05-28
LZC32010-11-29