FDA 510(k) Application Details - K072300

Device Classification Name	Latex Patient Examination Glove   More FDA Info for this Device
510(K) Number	K072300
Device Name	Latex Patient Examination Glove
Applicant	PERUSAHAAN PELINDUNG GETAH (M) SDN BHD 2000 COLD SPRING ROAD DIXVILLE NOTCH, NH 03576 US Other 510(k) Applications for this Company
Contact	THOMAS N TILLOTSON Other 510(k) Applications for this Contact
Regulation Number	880.6250   More FDA Info for this Regulation Number
Classification Product Code	LYY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/17/2007
Decision Date	05/16/2008
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	Y
Expedited Review