FDA.reportPublic FDA data

ANSELL SEREMBAN SDN. BHD

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30104369323010436932ANSELL SEREMBAN SDN. BHD1N2026-01-01Lot 120 & 121, Jalan Senawang 3 Senawang Industrial Estate Seremban Negeri Sembilan MY 70450

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3174711369060441K990878BRIGHTWAY BRAND BLUE NITRILE EXAMINATION GLOVES (POWDER FREE)LZA1999-05-21
3174711110624182K990543BRIGHTWAY BRAND POLYMER COATED LATEX EXAMINATION GLOVE (POWDER FREE)LYY1999-04-09
3174711796888646K231902GAMMEX 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
3174711201759637K213289Gammex® PI Plus Glove-in-Glove™ System Tested For Use with Chemotherapy DrugsKGO2023-05-26
3174711614915310K211621Latex Surgical Gloves, Powder Free with Protein claim (50 micrograms or less)KGO2021-10-06
3174711935170480K210724ENCORE Latex Acclaim, Powder Free Latex Surgical Gloves with Protein Content Labeling Claim (50 ug/dm2 per glove of total aqueous extractable protein) and Tested for use with Chemotherapy drugs, GAMMEX Latex Standard, Powder Free Latex Surgical Gloves with Protein Content Labeling Claim (50 ug/dm2 per glove of total aqueous extractable protein) and Tested for use with Chemotherapy drugsKGO2021-08-03
3174711127270788K210656ENCORE Latex Ortho, Powder Free Latex Surgical Gloves with Protein Content Labeling Claim (<50µg/dm2 per glove of total aqueous extractable protein) and Tested for use with Chemotherapy drugs, GAMMEX Latex Ortho, Powder Free Latex Surgical Gloves with Protein Content Labeling Claim (<50 µg/dm2 per glove of total aqueous extractable protein) and Tested for use with Chemotherapy drugsKGO2021-06-24
3174711068021854K203705Latex Examination Glove, Powder free with Protein Content Labeling Claim (50 ug/g or less of total extractable Protein)LYY2021-08-20
3174711001317762K202765ENCORE Latex Textured Surgical Gloves, Powder Free with Protein Content Labeling Claim (50 micrograms or less) and Tested for use with Chemotherapy drugsKGO2021-05-27
3174711317856436K201857Powder Free Nitrile Examination Glove Black and Dual Color White-BlueLZA2021-08-20
3174712015571590K190241Sterile Latex Surgical Glove, Powder FreeKGO2019-12-30
3174711044324138K181857Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Low Dermatitis Potential. Tested for Use with Chemotherapy Drugs and Fentanyl CitrateLZA2018-11-20
3174711591617252K162858NITRILECARE NITRILE EXAMINATION GLOVES POWDER FREE, BLUE, CHEMOTESTLZC2017-07-24
3174711394823326K152593LATEX EXAMINATION GLOVE POWDER FREELYY2016-02-25
3174711809866520K142862POWDER FREE NITRILE EXAMINATION GLOVE, BLUE (Colored).LZA2015-01-16
3174711454132396K142858POWDER FREE NITRILE EXAMINATION GLOVE, WHITE (colored)LZA2015-02-09

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
KGO72023-10-20
LZA52021-08-20
LYY32021-08-20
LZC12017-07-24