FDA 510(k) Application Details - K981879

Device Classification Name	Polymer Patient Examination Glove   More FDA Info for this Device
510(K) Number	K981879
Device Name	Polymer Patient Examination Glove
Applicant	BESGLOVE MEDICARE SDN. BHD. LOT 6, JALAN P/2A, BANGI INDUS ESTATE, 43650 BANDAR BARU BANG SELANGOR DARUL EHSAN MY Other 510(k) Applications for this Company
Contact	LEE AIK LIM 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	05/28/1998
Decision Date	08/11/1998
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