FDA 510(k) Application Details - K983816

Device Classification Name	Polymer Patient Examination Glove   More FDA Info for this Device
510(K) Number	K983816
Device Name	Polymer Patient Examination Glove
Applicant	TOP GLOVE SDN. BHD. 41050 KLANG,SELANGOR DARUL EHSAN MY Other 510(k) Applications for this Company
Contact	T.S. PUON 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	10/29/1998
Decision Date	12/04/1998
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