FDA 510(k) Application Details - K970222

Device Classification Name	Latex Patient Examination Glove   More FDA Info for this Device
510(K) Number	K970222
Device Name	Latex Patient Examination Glove
Applicant	KOSSAN LATEX INDUSTRIES (M) SDN. BHD. LOT 16632, 5-1/4 MILES, JALAN MERU KELANG, SELANGOR 41050 MY Other 510(k) Applications for this Company
Contact	LIM KUANG SIA 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	01/21/1997
Decision Date	06/24/1997
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