FDA 510(k) Application Details - K093264

Device Classification Name	Vinyl Patient Examination Glove   More FDA Info for this Device
510(K) Number	K093264
Device Name	Vinyl Patient Examination Glove
Applicant	QINGDAO LANG HUI IMPORT & EXPORT CO., LTD SHANDONG INTERNATIONAL TRADE MANSION 51 TAIPING QINGDAO, SHANDONG 266000 CN Other 510(k) Applications for this Company
Contact	MARSHAL MA 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	10/19/2009
Decision Date	05/28/2010
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