FDA 510(k) Application Details - K053366

Device Classification Name	Polymer Patient Examination Glove   More FDA Info for this Device
510(K) Number	K053366
Device Name	Polymer Patient Examination Glove
Applicant	PT. MAHAKARYA INTI BUANA J1. SEI BELUMAI, DESA DALU 10 A DUSUN I NO. 18, TANJUNG MORAWA, SUMUT 20362 ID Other 510(k) Applications for this Company
Contact	SASITHARAN NAIR 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	12/05/2005
Decision Date	03/30/2006
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