PROFESSIONAL LATEX SDN. BHD.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30429569523042956952PROFESSIONAL LATEX SDN. BHD.1N2026-01-01LOT 14202, JALAN PERUSAHAAN 3, KAWASAN PERUSAHAAN KAMUNTING KAMUNTING Perak MY 34600

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3461671344366031K220088Powder Free Nitrile Examination Glove, Non-Sterile, and Tested for Use with Chemotherapy Drugs and Fentanyl CitrateLZA2023-03-30
3461671944377472K173053POWDER FREE LATEX EXAMINATION GLOVELYY2018-06-06
3461671141974381K171667Powder Free Nitrile Examination GloveLZA2017-09-08

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LZA22023-03-30
LYY12018-06-06