FDA 510(k) Application Details - K972838

Device Classification Name	Polymer Patient Examination Glove   More FDA Info for this Device
510(K) Number	K972838
Device Name	Polymer Patient Examination Glove
Applicant	ABSOLUTE SYNTHETIC TECHNOLOGIES MALAYSIA SDN. BHD. PT 4004 KAMUNTING INDUSTRIAL ESTATE KAMUNTING, TAIPING, PERAK 34600 MY Other 510(k) Applications for this Company
Contact	WOLFE BIRKIE 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	08/01/1997
Decision Date	08/15/1997
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	Y
Expedited Review