FDA 510(k) Application Details - K033723

Device Classification Name	Vinyl Patient Examination Glove   More FDA Info for this Device
510(K) Number	K033723
Device Name	Vinyl Patient Examination Glove
Applicant	BAODING GUANZHONG GLOVE CO., LTD. 17A STERLING ROAD NORTH BILLERICA, MA 01862 US Other 510(k) Applications for this Company
Contact	HUAN-CHUNG LI 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	11/26/2003
Decision Date	02/24/2004
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