FDA.reportPublic FDA data

Molnlycke Health Care SDN BHD

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
96100541000207790Molnlycke Health Care SDN BHD1N2026-01-01LOT 9, LORONG PERUSAHAAN 4 KULIM INDUSTRIAL ESTATE KULIM Kedah MY 09000
30253556683025355668Molnlycke Health Care SDN BHD1N2026-01-01Lot 12A, Jalan Hi-Tech 7 Industrial Zone Phase 2, Kulim Hi-Tech Park Kulim Kedah MY 09090

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
768871565531151K971514REGENT BIOGEL DIAGNOSTIC PROCEDURE GLOVELYY1997-10-29
768871079323936K190077Biogel® PI UltraTouch S Surgical Glove, Biogel® Pl Ultra Touch S Indicator UndergloveKGO2019-05-24
3119751079323936K190077Biogel® PI UltraTouch S Surgical Glove, Biogel® Pl Ultra Touch S Indicator UndergloveKGO2019-05-24
768871615503784K150146Biogel PI Micro Indicator UndergloveKGO2015-08-31
768871276934488K141719BIOGEL PL MICRO SURGICAL GLOVEKGO2014-09-04
768871666589220K112257BIOGEL PI ORTHOPRO BROWN SURGICAL GLOVEKGO2011-09-20
3119751666589220K112257BIOGEL PI ORTHOPRO BROWN SURGICAL GLOVEKGO2011-09-20
768871084260065K081180SKINSENSE POLYISOPRENE UNDERGLOVEKGO2008-08-26
3119751084260065K081180SKINSENSE POLYISOPRENE UNDERGLOVEKGO2008-08-26
768871909315816K071700BIOGEL SENSOR SURGEON'S GLOVE WITH NON-PYROGENIC STATEMENTKGO2007-09-11
3119751909315816K071700BIOGEL SENSOR SURGEON'S GLOVE WITH NON-PYROGENIC STATEMENTKGO2007-09-11
768871976534468K071565BIOGEL INDICATOR UNDERGLOVE WITH NON-PYROGENIC STATEMENTKGO2007-09-10
3119751976534468K071565BIOGEL INDICATOR UNDERGLOVE WITH NON-PYROGENIC STATEMENTKGO2007-09-10
3119751020620132K071465BIOGEL ORTHOPAEDIC SURGICAL GLOVE WITH NON-PRYOGENIC STATEMENTKGO2007-09-11
768871020620132K071465BIOGEL ORTHOPAEDIC SURGICAL GLOVE WITH NON-PRYOGENIC STATEMENTKGO2007-09-11
768871004033008K071414BIOGEL ECLIPSE, LATEX, POWDER FREE, INDICATOR UNDERGLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)KGO2007-09-10
3119751004033008K071414BIOGEL ECLIPSE, LATEX, POWDER FREE, INDICATOR UNDERGLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)KGO2007-09-10
768871583280660K053443BIOGEL ECLIPSE NON-PYROGENIC LATEX POWDER-FREE STERILE SURGEON'S GLOVEKGO2006-02-01
3119751583280660K053443BIOGEL ECLIPSE NON-PYROGENIC LATEX POWDER-FREE STERILE SURGEON'S GLOVEKGO2006-02-01
768871499195386K053442BIOGEL SKINSENSE POLY-ISOPRENE POWDER-FREE NON-LATEX GLOVEKGO2006-03-07
3119751499195386K053442BIOGEL SKINSENSE POLY-ISOPRENE POWDER-FREE NON-LATEX GLOVEKGO2006-03-07
768871443707334K053441BIOGEL LATEX POWDER FREE STERILE SURGEON'S GLOVEKGO2006-04-10
768871920169413K053102BIOGEL SKINSENSE POWDER-FREE NON-LATEX SURGEON'S GLOVEKGO2006-03-10
3119751920169413K053102BIOGEL SKINSENSE POWDER-FREE NON-LATEX SURGEON'S GLOVEKGO2006-03-10
768871634098606K050899BIOGEL LATEX STERILE POWDER-FREE GLOVEKGO2005-08-12
768871206232251K050184BIOGEL SKINSENSE POLY-ISOPRENE POWDER-FREE NON-LATEX GLOVEKGO2005-03-16
3119751206232251K050184BIOGEL SKINSENSE POLY-ISOPRENE POWDER-FREE NON-LATEX GLOVEKGO2005-03-16
768871597951491K000421BIOGEL NEOTECH II POWDER-FREE NEOPRENE SURGEON'S GLOVEKGO2000-08-14
3119751597951491K000421BIOGEL NEOTECH II POWDER-FREE NEOPRENE SURGEON'S GLOVEKGO2000-08-14

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
KGO282019-05-24
LYY11997-10-29