FDA 510(k) Application Details - K980803

Device Classification Name	Latex Patient Examination Glove   More FDA Info for this Device
510(K) Number	K980803
Device Name	Latex Patient Examination Glove
Applicant	KENWELL INTERNATIONAL LTD. 55 NORTHERN BLVD.,SUITE 410 GREAT NECK, NY 11021 US Other 510(k) Applications for this Company
Contact	SUSAN D GOLDSTEIN-FALK 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	03/02/1998
Decision Date	04/03/1998
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	N
Expedited Review