FDA 510(k) Application Details - K974518

Device Classification Name	Latex Patient Examination Glove   More FDA Info for this Device
510(K) Number	K974518
Device Name	Latex Patient Examination Glove
Applicant	YTY INDUSTRY (MANJUNG) SDN. BHD. LOT 2935B KG BATU 9 KEBUN BARU JALAN MASJID TELOK PANGLIMA KUALA LANGAT SELANGOR D.E. 42500 MY Other 510(k) Applications for this Company
Contact	LEONARD FRIER 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	12/02/1997
Decision Date	12/12/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	Y
Expedited Review