FDA 510(k) Application Details - K110979

Device Classification Name	Polymer Patient Examination Glove   More FDA Info for this Device
510(K) Number	K110979
Device Name	Polymer Patient Examination Glove
Applicant	ADVANCED MEDICAL PRODUCTS SDN BHD LOT 8961 & 8964, BATU 19 JALAN BRUAS AYER TAWAR 32400 MY Other 510(k) Applications for this Company
Contact	ZAHARI DARUS Other 510(k) Applications for this Contact
Regulation Number	880.6250   More FDA Info for this Regulation Number
Classification Product Code	LZA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/07/2011
Decision Date	10/20/2011
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