FDA 510(k) Application Details - K090464

Device Classification Name	Polymer Patient Examination Glove   More FDA Info for this Device
510(K) Number	K090464
Device Name	Polymer Patient Examination Glove
Applicant	PT MAHAKARYA INTI BUANA JL.SEI BELUMAI DESA DALU 10A DUSUN I TANJUNG MORAWA, SUMUT 20362 ID Other 510(k) Applications for this Company
Contact	AZMAN ISMAIL 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	02/23/2009
Decision Date	04/23/2009
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