FDA 510(k) Application Details - K093500

Device Classification Name	Patient Examination Glove, Specialty   More FDA Info for this Device
510(K) Number	K093500
Device Name	Patient Examination Glove, Specialty
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	LZC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/12/2009
Decision Date	01/19/2010
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