FDA 510(k) Application Details - K061504

Device Classification Name	Polymer Patient Examination Glove   More FDA Info for this Device
510(K) Number	K061504
Device Name	Polymer Patient Examination Glove
Applicant	LIWE TRADING 49,JALAN SS 2/19 47300 PETALING JAYA SELANGOR DARUL EHSAN 47300 MY Other 510(k) Applications for this Company
Contact	K M LEE 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	06/01/2006
Decision Date	03/19/2007
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