FDA 510(k) Application Details - K072639

Device Classification Name	Latex Patient Examination Glove   More FDA Info for this Device
510(K) Number	K072639
Device Name	Latex Patient Examination Glove
Applicant	SHANDONG YUYUAN LATEX GLOVES COMPANY LTD. 1296 INDUSTRIAL PARK LINQING CITY, SHANDONG 252600 CN Other 510(k) Applications for this Company
Contact	JESSIE SUN 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	09/18/2007
Decision Date	11/19/2007
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review