FDA 510(k) Application Details - K092498

Device Classification Name	Polymer Patient Examination Glove   More FDA Info for this Device
510(K) Number	K092498
Device Name	Polymer Patient Examination Glove
Applicant	LAGLOVE (M) SDN. BHD. LOT 478, JALAN SIMPANG BALAK, OFF BATU 13, JALAN CHERAS KAJANG, SELANGOR, DARUL EHSAN 43000 MY Other 510(k) Applications for this Company
Contact	G. BASKARAN Other 510(k) Applications for this Contact
Regulation Number	880.6250   More FDA Info for this Regulation Number
Classification Product Code	LZA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/14/2009
Decision Date	11/20/2009
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review