FDA 510(k) Application Details - K111300

Device Classification Name	Polymer Patient Examination Glove   More FDA Info for this Device
510(K) Number	K111300
Device Name	Polymer Patient Examination Glove
Applicant	PT. MAHAKARYA INTI BUANA DALU 10, DELI SERDANG T. MORAWA SUMATERA UTARA 20362 ID Other 510(k) Applications for this Company
Contact	LINA NG 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	05/09/2011
Decision Date	08/12/2011
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review