FDA 510(k) Application Details - K002448

Device Classification Name	Latex Patient Examination Glove   More FDA Info for this Device
510(K) Number	K002448
Device Name	Latex Patient Examination Glove
Applicant	OON CORP. RESOURCES 59 SENAWANG INDUSTRIAL ESTATE SEREMBAN 70450 MY Other 510(k) Applications for this Company
Contact	CLEMENT K K OON 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	08/09/2000
Decision Date	09/11/2000
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