FDA 510(k) Application Details - K013821

Device Classification Name	Latex Patient Examination Glove   More FDA Info for this Device
510(K) Number	K013821
Device Name	Latex Patient Examination Glove
Applicant	TOP QUALITY MFG., INC. 6800 LINDBERGH AVE. PHILADELPHIA, PA 19142 US Other 510(k) Applications for this Company
Contact	MARC SINKOW 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	11/16/2001
Decision Date	03/05/2002
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