FDA 510(k) Application Details - K981064

Device Classification Name	Polymer Patient Examination Glove   More FDA Info for this Device
510(K) Number	K981064
Device Name	Polymer Patient Examination Glove
Applicant	PT. IRAMA DINAMIKA LATEX JL. KAPTEN PATTIMURA NO. 23/ 235 MEDAN 21053 INDONESIA ID Other 510(k) Applications for this Company
Contact	ANIL TANEJA 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	03/23/1998
Decision Date	11/05/1998
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