FDA 510(k) Application Details - K031335

Device Classification Name	Latex Patient Examination Glove   More FDA Info for this Device
510(K) Number	K031335
Device Name	Latex Patient Examination Glove
Applicant	TAN SIN LIAN INDUSTRIES SDN. BHD. 1133, NORTH 4TH ST. PHILADEPHIA, PA 19123 US Other 510(k) Applications for this Company
Contact	LEE TAN 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	04/28/2003
Decision Date	10/16/2003
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