FDA 510(k) Application Details - K083908

Device Classification Name	Polymer Patient Examination Glove   More FDA Info for this Device
510(K) Number	K083908
Device Name	Polymer Patient Examination Glove
Applicant	INNOVATIVE GLOVES CO; LTD 830 MOO 4 SANAMBIN-BANKLANG RD TAMBON KUANLANG, AMPHUR HATYAI SONGKHLA 90110 TH Other 510(k) Applications for this Company
Contact	RAJEEV K 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	12/30/2008
Decision Date	03/06/2009
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