FDA 510(k) Application Details - K091427

Device Classification Name	Vinyl Patient Examination Glove   More FDA Info for this Device
510(K) Number	K091427
Device Name	Vinyl Patient Examination Glove
Applicant	SHUN DA (XINGHUA) CO., LTD LOT20, TIAN SHUI HUA TING YUAN XIANGHUA CITY JIANGSU 225700 CN Other 510(k) Applications for this Company
Contact	ZHANG YAN 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	05/13/2009
Decision Date	06/23/2009
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