FDA 510(k) Application Details - K954221

Device Classification Name	Latex Patient Examination Glove   More FDA Info for this Device
510(K) Number	K954221
Device Name	Latex 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	EU JIN KUAN Other 510(k) Applications for this Contact
Regulation Number	880.6250   More FDA Info for this Regulation Number
Classification Product Code	LYY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/11/1995
Decision Date	05/03/1996
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