FDA 510(k) Application Details - K072227

Device Classification Name	Vinyl Patient Examination Glove   More FDA Info for this Device
510(K) Number	K072227
Device Name	Vinyl Patient Examination Glove
Applicant	PINNACLE CO., LTD. 240 RENMIN ROAD LINZI SHANDONG CN Other 510(k) Applications for this Company
Contact	DAVID DING Other 510(k) Applications for this Contact
Regulation Number	880.6250   More FDA Info for this Regulation Number
Classification Product Code	LYZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/10/2007
Decision Date	02/15/2008
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	N
Expedited Review