FDA 510(k) Application Details - K092492

Device Classification Name	Latex Patient Examination Glove   More FDA Info for this Device
510(K) Number	K092492
Device Name	Latex Patient Examination Glove
Applicant	WEAR SAFE (MALAYSIA) SDN. BHD. LOT PT 13726,JALAN HAJI SALLEH OFF JALAN MERU KLANG, SELANGOR, DARUL EHSAN 41050 MY Other 510(k) Applications for this Company
Contact	S H 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	08/13/2009
Decision Date	10/21/2009
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