FDA.reportPublic FDA data

ANSELL N.P. SDN. BHD.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
80437363003221560ANSELL N.P. SDN. BHD.1N2026-01-01LOT 80, AIR KEROH IND. ESTATE MELAKA MY 75450

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
95071177685800K984558DERMA PRENE POWDER-FREE SYNTHETIC SURGICAL GLOVES (CHEMOTHERAPY USE)KGO1999-02-26
95071396960487K983489ENCORE MARK IV POWDER FREE POLYMER COATED LATEX SURGICAL GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LE)KGO1998-12-14
95071718438119K982453NON-STERILE E.P. LATEX EXAMINATION GLOVELYY1998-11-30
95071937960900K850635ANSELL NO POWDER SURGEON'S GLOVESKGO1985-06-26
95071796888646K231902GAMMEX PI Hybrid Micro (340002055); GAMMEX PI Hybrid Micro (340002060); GAMMEX PI Hybrid Micro (340002065); GAMMEX PI Hybrid Micro (340002070); GAMMEX PI Hybrid Micro (340002075); GAMMEX PI Hybrid Micro (340002080); GAMMEX PI Hybrid Micro (340002085); GAMMEX PI Hybrid Micro (340002090)KGO2023-10-20
95071201759637K213289Gammex® PI Plus Glove-in-Glove™ System Tested For Use with Chemotherapy DrugsKGO2023-05-26
95071129242051K190018Gammex Non Latex PI White Polyisoprene Surgical Gloves Tested for Use with Chemotherapy DrugsKGO2019-05-23
95071156483364K182948Gammex PI Hybrid Surgical Gloves Tested for Use with Chemotherapy DrugsKGO2019-03-22
95071487912892K171375Gammex PI Breach Detect Powder Free Surgical GloveKGO2018-02-06
95071006159923K151694Gammex PI Hybrid Surgical GlovesKGO2016-03-09
95071050235627K111139DERMA PRENE ISOTOUCH GREEN STERILE POWDER-FREE POLYISOPRENE SURGICAL GOVES, TESTED FOR UKGO2011-09-02
95071565964755K103714ENCORE ACCLAIM STERILE POWDER-FREE LATEX SURGICAL GLOVES, TESTED FOR USE WITH CHEMOTHERAKGO2011-07-07
95071297193542K071746DERMA PRENE PI OR ISOTOUCH GREEN STERILE POWDER-FREE SYNTHETIC POLYISOPRENE SURGICAL GLOVESKGO2007-12-13
95071094947148K051793ENCORE STERILE POWDER-FREE LATEX SURGICAL GLOVE WITH PROPRIETARY COATING (CONTAINING GLYCERINE)KGO2005-08-17
95071801745781K000295ENCORE MICROPTIC POWDER FREE LATEX SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)KGO2000-02-16
95071979379345

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
KGO142023-10-20
LYY11998-11-30