FDA 510(k) Application Details - K130846

Device Classification Name	Polymer Patient Examination Glove   More FDA Info for this Device
510(K) Number	K130846
Device Name	Polymer Patient Examination Glove
Applicant	INDUSTRIAL CLOTHINGS, LTD. D17, SEETHAWAKA EXPORT PROCESSING ZONE AVISSAWELLA, WESTERN PROVINCE 10700 LK Other 510(k) Applications for this Company
Contact	S.N. HARI 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	03/27/2013
Decision Date	08/08/2013
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