FDA 510(k) Application Details - K102161

Device Classification Name	Vinyl Patient Examination Glove   More FDA Info for this Device
510(K) Number	K102161
Device Name	Vinyl Patient Examination Glove
Applicant	SHANDONG BLUE SAIL INNOVATION CO., LTD. EAST SIDE OF XING'AN ROAD, DONGCHENG STREET OFFIE, LINQU WEIFANG, SHANDONG 262600 CN Other 510(k) Applications for this Company
Contact	YONGCHEN ZHANG 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	08/02/2010
Decision Date	10/08/2010
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