FDA 510(k) Application Details - K100694

Device Classification Name	Latex Patient Examination Glove   More FDA Info for this Device
510(K) Number	K100694
Device Name	Latex Patient Examination Glove
Applicant	TEKMEDIC (M) SDN BHD PLOT 4, TANJUNG KLING INDUSTRIAL AREA, TANJUNG BRUAS JETTY, TANJUNG KLING, MELAKA 76400 MY Other 510(k) Applications for this Company
Contact	PATRICK LEONG 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	03/11/2010
Decision Date	06/25/2010
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