Pt Medisafe Technologies

FDA Filings

This page includes the latest FDA filings for Pt Medisafe Technologies. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number9616501
FEI Number3002955419
NameBlix Winston
Owner & OperatorPT. MEDISAFE TECHNOLOGIES
Contact AddressJl. Batang Kuis Gg. Tambak Rejo / PSR IX
Medan ID-SU Sumatera Utara 20362 ID
US Agent
Importing Logistics Registration
ImporterAMERICAN HEALTHCARE PRODUCTS INC
Address1028 WESTMINSTER AVE
Alhambra, CA 91803 UNITED STATES
Importer TypeDISTRIBUTOR
Importing Logistics Registration
ImporterCLINICAL SUPPLY COMPANY
Address9230 SEWARD ROAD
Fairfield, OH 45014 UNITED STATES
Importer TypeDISTRIBUTOR
Importing Logistics Registration
ImporterCYPRESS MEDICAL PRODUCTS, LTD
Address1202 S ROUTE 31
McHenry, IL 60050 UNITED STATES
Importer TypeDISTRIBUTOR
Importing Logistics Registration
ImporterMICROFLEX CORPORATION
Address150 FIELD DR SUITE 210
Lake Forest, IL 60045 UNITED STATES
Importer TypeDISTRIBUTOR
Importing Logistics Registration
ImporterSmart Practice
Address3400 East Mcdowell Road Phoenix, AZ 85008
Phoenix, AZ 85008 UNITED STATES
Importer Typeinitial importer
Importing Logistics Registration
ImporterUNIGLOBE MANUFACTURING
Address7809 43RD STREET COURT NW GIG HARBOR WA
Gig Harbor, WA 98335 UNITED STATES
Importer TypeDISTRIBUTOR
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address2600 Mullinix Mill Road Mt. Airy, MD 21771
Mount Airy, MD 21771 US
Establishment TypeManufacture Medical Device

FDA Filings

Device
Company
DeviceDate
PT. Medisafe Technologies
Polychloroprene Powder Free Sterile Surgical Gloves, Low Dermatitis Potential And Tested For Use With Chemotherapy Drugs2020-09-16
PT. Medisafe Technologies
Polychloroprene Powder Free Sterile Surgical Gloves, White, Tested For Use With Chemotherapy Drugs2019-03-28
Pt. Medisafe Technologies
Polychloroprene Powder Free Sterile Surgical Gloves, White, Tested For Use With Chemotherapy2018-04-20
PT. MEDISAFE TECHNOLOGIES
Powder Free Polychloroprene Examination Gloves-Pink With Aloe Vera And Vitamin E2017-02-22
Blix Winston [PT. MEDISAFE TECHNOLOGIES]
Polychloroprene Powder-Free Surgical Glove Tested For Use With Chemotherapy Drugs-White & Green.2016-01-12
Blix Winston [PT. MEDISAFE TECHNOLOGIES]
Polychloroprene Powder-Free Surgical Glove Tested For Use With Chemotherapy Drugs-White & Green.2016-01-12
PT MEDISAFE TECHNOLOGIES
Powder-Free Polyisoprene Sterile Surgical Gloves In White Color Tested For Use With Chemotherapy Drugs, Powder-Free Polyisoprene Sterile Surgical Gloves In Green Color.2015-11-02
PT MEDISAFE TECHNOLOGIES
Polychloroprene Powder-free Surgical Glove (White) Tested For Use With Chemotherapy Drugs; Polychloroprene Powder-free Surgical Glove (Green) Tested For Use With Chemotherapy Drugs2015-07-14
PT. MEDISAFE TECHNOLOGIES
POWDER FREE POLYCHLOROPRENE LIGHT WIEGHT EXAMINATIONGLOVES- GREEN,BLUE AND PINK2014-07-03
Blix Winston [PT. MEDISAFE TECHNOLOGIES]
Powderfree Polyisoprene Surgical Gloves2013-11-12
PT. MEDISAFE TECHNOLOGIES
POWDERFREE POLYISOPRENE SURGICAL GLOVES2012-02-17
PT. MEDISAFE TECHNOLOGIES
BLUE POWDERFREE NITRILE EXAMINATION GLOVE2011-06-06
PT. MEDISAFE TECHNOLOGIES
POWDERFREE BLACK NITRILE EXAMINATION GLOVES2010-11-22
PT. MEDISAFE TECHNOLOGIES
POWDER FREE NITRILE PATIENT EXAMINATION GLOVES WITH CHEMO LABELING CLAIM2008-12-09
Blix Winston [PT. MEDISAFE TECHNOLOGIES]
Latex Examination Gloves2007-12-05
Blix Winston [PT. MEDISAFE TECHNOLOGIES]
Synthetic Rubber Examination Gloves2007-12-05
Blix Winston [PT. MEDISAFE TECHNOLOGIES]
Nitrile Examination Gloves2007-12-05
Blix Winston [PT. MEDISAFE TECHNOLOGIES]
Latex Examination gloves2007-12-05
Blix Winston [PT. MEDISAFE TECHNOLOGIES]
Latex Examination Gloves2007-12-05
Blix Winston [PT. MEDISAFE TECHNOLOGIES]
Sterile Synthetic Rubber Exam Glove2007-12-05
Blix Winston [PT. MEDISAFE TECHNOLOGIES]
Sterile Polychloroprene Examination2007-12-05
Blix Winston [PT. MEDISAFE TECHNOLOGIES]
Latex Examination Gloves2007-12-05
PT. MEDISAFE TECHNOLOGIES
POWDERFREE POLYCHLOROPRENE STERILE EXAMINATION GLOVES2005-07-12
PT. MEDISAFE TECHNOLOGIES
POWDERFREE COLORED AND FLAVORED CHLOREPRENE PATIENT EXAMINATION GLOVES TESTED FOR CHEMO USE2004-12-01
PT. MEDISAFE TECHNOLOGIES
MODIFICATION TO POWDERFREE COLORED AND FLAVORED CHLOROPRENE PATIENT EXAMINATION GLOVES2004-04-22
PT. MEDISAFE TECHNOLOGIES
POWDERFREE POLYCHLOROPRENE STERILIZED SURGICAL GLOVES2003-03-14
PT. MEDISAFE TECHNOLOGIES
POWDERFREE COLORED LATEX EXAMINATION GLOVES (PINK, BLUE, GREEN, AND WHITE) WITH PROTEIN CONTENT LABELING CLAIM (50 MICR02001-05-03

Related Finance Registrations
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2020092638697Singapore,Singapore -> Oakland, California2,700 CASES = 3,240,000 PIECES GLOVES OF GLOVES REFLECTION CHLOR PF EXAM GRN2700 CAS
2020092524228Singapore,Singapore -> Oakland, California2,700 CASES = 3,240,000 PIECES GLOVES OF GLOVES REFLECTION CHLOR PF EXAM GRN2700 CAS
202009257054Port Swettenham,Malaysia -> New York/Newark Area, Newark, New JerseyGLOVE3810 CAS
2020092459785Port Swettenham,Malaysia -> New York, New YorkGLOVES OF CRITERION CR CHLOR GLOV2653 CAS
2020092459313Port Swettenham,Malaysia -> New York, New YorkGLOVES3810 CAS
2020092315390Singapore,Singapore -> Long Beach, California500 CASES = 600,000 PIECES GLOVES OF GLOVES LE SOOTHE POLYCHLOR PF EXAM SAPPHIRE500 CAS
202009229780Singapore,Singapore -> Oakland, California2,700 CASES = 3,240,000 PIECES GLOVES OF GLOVES PINK RIBBON POLYCHLOR PF EXAM PNK2700 CAS
202009229778Singapore,Singapore -> Oakland, California600 CASES = 720,000 PIECES GLOVES OF GLOVES REFLECTION CHLOR PF EXAM GRN600 CAS
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