FDA 510(k) Application Details - K021659

Device Classification Name	Latex Patient Examination Glove   More FDA Info for this Device
510(K) Number	K021659
Device Name	Latex Patient Examination Glove
Applicant	P.T. HEALTHCARE GLOVINDO JL. KOL. YOS SUDARSO K.M. 10 KAWASAN INDUSRI MEDAN MEDAN 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	05/20/2002
Decision Date	08/12/2002
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