FDA 510(k) Application Details - K011563

Device Classification Name	Latex Patient Examination Glove   More FDA Info for this Device
510(K) Number	K011563
Device Name	Latex Patient Examination Glove
Applicant	U.O.P. RUBBER PRODUCTS SDN BHD 878 JALAN BANDAR BARU, NIBONG TEBAL PENANG 14300 MY Other 510(k) Applications for this Company
Contact	CHUA BENG CHUAN Other 510(k) Applications for this Contact
Regulation Number	880.6250   More FDA Info for this Regulation Number
Classification Product Code	LYY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/21/2001
Decision Date	06/05/2001
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