FDA 510(k) Application Details - K023915

Device Classification Name	Latex Patient Examination Glove   More FDA Info for this Device
510(K) Number	K023915
Device Name	Latex Patient Examination Glove
Applicant	SANREA HEALTHCARE PRIVATE LIMITED COCHIN SPECIAL ECONOMIC ZONE KAKKANAD, COCHIN KERALA 682037 IN Other 510(k) Applications for this Company
Contact	JOSEPH J E PEREIRA 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	11/25/2002
Decision Date	02/11/2003
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