FDA.reportPublic FDA data

PT. MEDISAFE TECHNOLOGIES

Matched from indexed company URL: PT. Medisafe Technologies

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
96165013002955419PT. MEDISAFE TECHNOLOGIES1N2026-01-01Jl. Batang Kuis Gg. Tambak Rejo / PSR IX, Desa/Kelurahan Buntu B Kab. Deli Serdang Sumatera Utara ID 20362

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
157392058949411K984449NATURAL RUBBER PRE-POWDERED COLORED & FLAVORED PATIENT EXAMINATION GLOVES WITH PROTEIN LABELLING CLAIMLYY1999-03-19
157391533206533K981064POWDERFREE COLORED AND FLAVORED CHLOROPRENE PATIENT EXAMINATION GLOVESLZA1998-11-05
157391434802501K972306POWDERFREE COLORED AND FLAVORED NITRILE COPOLYMER PATIENT EXAMINATION GLOVES-MEDICAL DEVICELZA1997-09-12
157391552064666K962518NITRILE COPOLYMER PATIENT EXAMINATION GLOVESLZA1996-12-19
157391832604818K953462PATIENT EXAMINATION GLOVESLYY1996-01-04
157391874643280K913776PATIENT EXAMINATION GLOVESLYY1991-11-07
157391053086799K231435KIMTECH™ Polaris™ Xtra Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric AcidLZA2023-08-28
157391584350124K231021KIMTECH™ Polaris™ Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric AcidLZA2023-07-21
157391410069403K202536Non-sterile, Powder Free Nitrile Examination Aloe Vera Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, And Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs and Fentanyl CitrateLZA2021-08-11
157391291106417K200453NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVES, LOW DERMATITIS POTENTIAL, AND TESTED FOR USE WITH CHEMOTHERAPY DRUGS BLUE-ACLZA2020-05-01
157391074361389K182383Non-Sterile, PF Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs-BlueLZC2019-03-19
157391284387074K182176Polychloroprene Powder Free Sterile Surgical Gloves, White, Tested for Use with Chemotherapy DrugsKGO2019-03-28
157391718086759K173258Polychloroprene Powder Free Sterile Surgical Gloves, White, Tested for Use with ChemotherapyKGO2018-04-20
157391816354859K171737Micro Touch Denta Glove Nitrile Hydrasoft Patient Examination GlovesLZA2017-12-29
157391081221271K162095Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs (Original Blue, Cobalt Blue)LZA2016-11-02
157391375142144K150238SensiCare Sterile Powder-Free Polymer Coated Polyisoprene Surgical glove, With Aloe Vera (Tested of Use with Chemotherapy Drugs) -Natural ColorKGO2015-11-27
157391640472557K142941Powder-Free Polyisoprene Sterile Surgical Gloves in White Color Tested for Use with Chemotherapy Drugs, Powder-Free Polyisoprene Sterile Surgical Gloves in Green Color.KGO2015-11-02
157391421898794K133123NON STERILE, POWEDER FREE BLUE NITRILE EXAMINATION GLOVES - 8623FLZA2014-05-30
157391842929770K112654POWDERFREE POLYISOPRENE SURGICAL GLOVESKGO2012-02-17
157391513694756K102623BLUE POWDERFREE NITRILE EXAMINATION GLOVELZA2011-06-06
157391604481180K042567POWDERFREE POLYCHLOROPRENE STERILIZED SURGICAL GLOVES WITH ALOE VERA AND VITAMIN EKGO2005-01-13
157391288303018K041913POWDERFREE COLORED AND FLAVORED CHLOREPRENE PATIENT EXAMINATION GLOVES TESTED FOR CHEMO USELZA2004-12-01
157391844074264K040607MODIFICATION TO POWDERFREE COLORED AND FLAVORED CHLOROPRENE PATIENT EXAMINATION GLOVESLZA2004-04-22
157391019402361K030228POWDERFREE POLYCHLOROPRENE STERILIZED SURGICAL GLOVESKGO2003-03-14
157391636449581K022765NITRILE POWDER-FREE EXAMINATION GLOVESLZA2002-10-11
157391034127928
157391184627212
157391210452963
157391212304035
157391257248474
157391320977309
157391368372693
157391474494647
157391504696816
157391623080766
157391649440815
157391794454039
157391865194956
157391868941757
157391987300198
157392065640709

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LZA142023-08-28
KGO72019-03-28
LYY31999-03-19
LZC12019-03-19

PMN#