FDA.reportPublic FDA data

Molnlycke Health Care Sdn. Bhd.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30103091123010309112Molnlycke Health Care Sdn. Bhd.1N2026-01-01Plot 204, Kawasan Perindustrian Kuala Ketil Kuala Ketil Kedah MY 09300

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1832571565531151K971514REGENT BIOGEL DIAGNOSTIC PROCEDURE GLOVELYY1997-10-29
1832571079323936K190077Biogel® PI UltraTouch S Surgical Glove, Biogel® Pl Ultra Touch S Indicator UndergloveKGO2019-05-24
1832571615503784K150146Biogel PI Micro Indicator UndergloveKGO2015-08-31
1832571276934488K141719BIOGEL PL MICRO SURGICAL GLOVEKGO2014-09-04
1832571666589220K112257BIOGEL PI ORTHOPRO BROWN SURGICAL GLOVEKGO2011-09-20
1832571084260065K081180SKINSENSE POLYISOPRENE UNDERGLOVEKGO2008-08-26
1832571909315816K071700BIOGEL SENSOR SURGEON'S GLOVE WITH NON-PYROGENIC STATEMENTKGO2007-09-11
1832571976534468K071565BIOGEL INDICATOR UNDERGLOVE WITH NON-PYROGENIC STATEMENTKGO2007-09-10
1832571020620132K071465BIOGEL ORTHOPAEDIC SURGICAL GLOVE WITH NON-PRYOGENIC STATEMENTKGO2007-09-11
1832571004033008K071414BIOGEL ECLIPSE, LATEX, POWDER FREE, INDICATOR UNDERGLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)KGO2007-09-10
1832571583280660K053443BIOGEL ECLIPSE NON-PYROGENIC LATEX POWDER-FREE STERILE SURGEON'S GLOVEKGO2006-02-01
1832571499195386K053442BIOGEL SKINSENSE POLY-ISOPRENE POWDER-FREE NON-LATEX GLOVEKGO2006-03-07
1832571443707334K053441BIOGEL LATEX POWDER FREE STERILE SURGEON'S GLOVEKGO2006-04-10
1832571920169413K053102BIOGEL SKINSENSE POWDER-FREE NON-LATEX SURGEON'S GLOVEKGO2006-03-10
1832571634098606K050899BIOGEL LATEX STERILE POWDER-FREE GLOVEKGO2005-08-12
1832571206232251K050184BIOGEL SKINSENSE POLY-ISOPRENE POWDER-FREE NON-LATEX GLOVEKGO2005-03-16
1832571597951491K000421BIOGEL 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
KGO162019-05-24
LYY11997-10-29