FDA 510(k) Application Details - K040108

Device Classification Name	Vinyl Patient Examination Glove   More FDA Info for this Device
510(K) Number	K040108
Device Name	Vinyl Patient Examination Glove
Applicant	EST INTERNATIONAL CORPORATION 7668 BELPINE PLACE RANCHO CUCAMONGA, CA 91730 US Other 510(k) Applications for this Company
Contact	ELIZABETH DENG Other 510(k) Applications for this Contact
Regulation Number	880.6250   More FDA Info for this Regulation Number
Classification Product Code	LYZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/20/2004
Decision Date	08/17/2004
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