FDA 510(k) Application Details - K984311

Device Classification Name	Polymer Patient Examination Glove   More FDA Info for this Device
510(K) Number	K984311
Device Name	Polymer Patient Examination Glove
Applicant	SUMIRUBBER INDUSTRIES (KEDAH) SDN. BHD. LOT 44, 45 & 86, BAKAR ARANG INDUSTRIAL ESTATE SUNGAI PETANI, KEDAH 08000 MY Other 510(k) Applications for this Company
Contact	HIDEAKI OCHIAI 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	12/02/1998
Decision Date	02/09/1999
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