FDA 510(k) Application Details - K974853

Device Classification Name	Latex Patient Examination Glove   More FDA Info for this Device
510(K) Number	K974853
Device Name	Latex Patient Examination Glove
Applicant	P.T. HEALTHCARE GLOVINDO JALAN KEBUN SIRIH 39 JAKARTA 10340 ID Other 510(k) Applications for this Company
Contact	ELLEN HUTAPEA 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	12/29/1997
Decision Date	02/09/1998
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