FDA.reportPublic FDA data

SEMPERMED KFT.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
96145023003189428SEMPERMED KFT.1N2026-01-0114 SOMFALVY U. SOPRON Gyor-Moson-Sopron HU 9400

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
94712008900529K250313Sterile Powder Free Synthetic Rubber Surgeon’s Gloves, Green Color, Tested For Use With Chemotherapy Drugs and Gastric AcidKGO2025-08-19
94712039882649K191860Sterile Powder-Free Synthetic Rubber Surgeon’s Glove with Low Dermatitis PotentialKGO2020-03-31
94711090772943K160781Sempermed Syntegra IR, Sterile Powder Free Synthetic Rubber Surgeons GlovesKGO2017-05-02
94711201624180K013560SEMPERMED SUPREME, SIZES 5.5, 6, 6.5, 7, 7.5, 8, 8.5, AND 9KGO2002-01-16

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
KGO42025-08-19