FDA 510(k) Application Details - K963804

Device Classification Name	Polymer Patient Examination Glove   More FDA Info for this Device
510(K) Number	K963804
Device Name	Polymer Patient Examination Glove
Applicant	HARTALEGA SDN BHD 9 JALAN KUANG BULAN TAMAN KEPONG INDUSTRIAL ESTATE KUALA LUMPUR 52100 MY Other 510(k) Applications for this Company
Contact	K.H. KUAN 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	09/23/1996
Decision Date	02/10/1997
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	N
Expedited Review