FDA 510(k) Application Details - K101293

Device Classification Name	Polymer Patient Examination Glove   More FDA Info for this Device
510(K) Number	K101293
Device Name	Polymer Patient Examination Glove
Applicant	PT. SMART GLOVE INDONESIA JL RAYA MEDAN-LUBUK PAKAM KM19 TANJONG MORAWA B,TANJONG MORAWA,DELI SERDANG,SUMATERA U 20362 ID Other 510(k) Applications for this Company
Contact	CHO S FONG 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	05/10/2010
Decision Date	07/01/2010
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