FDA 510(k) Application Details - K083624

Device Classification Name	Polymer Patient Examination Glove   More FDA Info for this Device
510(K) Number	K083624
Device Name	Polymer Patient Examination Glove
Applicant	COMFORT RUBBER GLOVES IND. SDN. BHD. LOT 821, JALAN MATANG 34750 MATANG TAIPING, PERAK MY Other 510(k) Applications for this Company
Contact	TAN K BENG 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	12/08/2008
Decision Date	02/10/2009
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