FDA 510(k) Application Details - K003309

Device Classification Name	Latex Patient Examination Glove   More FDA Info for this Device
510(K) Number	K003309
Device Name	Latex Patient Examination Glove
Applicant	WRP SPECIALTY PRODUCTS SDN. BHD. LOT11, JL.2,KAWASAN PERUSAHAAN BANDAR BARU SLAK TINGGI SELANGOR DAURL EHSAN, SEPANG 43900 MY Other 510(k) Applications for this Company
Contact	MOHD HAIZAN HUSSEIN 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	10/23/2000
Decision Date	11/22/2000
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review