FDA 510(k) Application Details - K111158

Device Classification Name	Latex Patient Examination Glove   More FDA Info for this Device
510(K) Number	K111158
Device Name	Latex Patient Examination Glove
Applicant	INNOVATIVE GLOVES CO; LTD 830 MOO 4 SANAMBIN-BANKLANG RD KUANLANG HATYAI, SONGKHLA 90110 TH Other 510(k) Applications for this Company
Contact	RAJEEV SOOD Other 510(k) Applications for this Contact
Regulation Number	880.6250   More FDA Info for this Regulation Number
Classification Product Code	LYY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/25/2011
Decision Date	08/10/2011
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