FDA 510(k) Application Details - K103670

Device Classification Name	Polymer Patient Examination Glove   More FDA Info for this Device
510(K) Number	K103670
Device Name	Polymer Patient Examination Glove
Applicant	INNOVATIVE GLOVES CO; LTD 800 MOO 4,SAAMBIN-BAN KLANG 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	LZA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/16/2010
Decision Date	03/31/2011
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