FDA 510(k) Application Details - K021308

Device Classification Name	Polymer Patient Examination Glove   More FDA Info for this Device
510(K) Number	K021308
Device Name	Polymer Patient Examination Glove
Applicant	GLOVCO (M) SDN. BHD. LOT 760,(BLOCK A),JALAN HAJI SIRAT,OFF JALAN MERU KLANG, SELANGOR D.E. 42100 MY Other 510(k) Applications for this Company
Contact	TAN PENG HOCK Other 510(k) Applications for this Contact
Regulation Number	880.6250   More FDA Info for this Regulation Number
Classification Product Code	LZA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/25/2002
Decision Date	05/14/2002
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