FDA 510(k) Application Details - K031625

Device Classification Name	Polymer Patient Examination Glove   More FDA Info for this Device
510(K) Number	K031625
Device Name	Polymer Patient Examination Glove
Applicant	PERUSAHAAN GETAH ASAS SDN BHD 1301 DEFENSE HIGHWAY GAMBRILLS, MD 21054-1928 US Other 510(k) Applications for this Company
Contact	JAMES F LOGAN 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	05/27/2003
Decision Date	08/01/2003
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