FDA 510(k) Application Details - K052985

Device Classification Name	Vinyl Patient Examination Glove   More FDA Info for this Device
510(K) Number	K052985
Device Name	Vinyl Patient Examination Glove
Applicant	TG MEDICAL (CHINA) INCORPORATION 3 XITANG ROAD XIZHANG TOWN ZHANGJIAGANG, JIANGSU PROVINCE 215614 CN Other 510(k) Applications for this Company
Contact	WU KIN YEAP 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	10/24/2005
Decision Date	01/19/2006
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