FDA 510(k) Application Details - K062917

Device Classification Name	Latex Patient Examination Glove   More FDA Info for this Device
510(K) Number	K062917
Device Name	Latex Patient Examination Glove
Applicant	WEAR SAFE MALAYSIA SDN. BHD. LOT 1, LEBOH HISHAMUDDIN SATU, NORTH KLANG STRAITS IND. AREA PORT KLANG, SELANGOR, D.E. 42000 MY Other 510(k) Applications for this Company
Contact	TK LOH 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	09/28/2006
Decision Date	11/02/2006
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