FDA 510(k) Application Details - K033086

Device Classification Name	Polymer Patient Examination Glove   More FDA Info for this Device
510(K) Number	K033086
Device Name	Polymer Patient Examination Glove
Applicant	PT. MEDISAFE TECHNOLOGIES GG. TAMBAK REJO DESA BUNTU BEDIMBAR TANJUNG MORAWA 20362 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	09/29/2003
Decision Date	02/26/2004
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