FDA 510(k) Application Details - K120336

Device Classification Name	Patient Examination Glove, Specialty   More FDA Info for this Device
510(K) Number	K120336
Device Name	Patient Examination Glove, Specialty
Applicant	HARTALEGA SDN BHD NO. 7, KAWASAN PERUSAHAAN SURIA BESTARI JAYA 45600 MY Other 510(k) Applications for this Company
Contact	NURUL AISYAH KONG 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	02/03/2012
Decision Date	06/25/2012
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