FDA 510(k) Application Details - K013537

Device Classification Name	Latex Patient Examination Glove   More FDA Info for this Device
510(K) Number	K013537
Device Name	Latex Patient Examination Glove
Applicant	KOON SENG SDN.BHD PTD 3274 BATU 4 1/2 JALAN BAKRI MUAR JOHOR 84200 MY Other 510(k) Applications for this Company
Contact	LIM WENG HENG 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	10/23/2001
Decision Date	12/07/2001
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