FDA 510(k) Application Details - K052031

Device Classification Name	Surgeon'S Gloves   More FDA Info for this Device
510(K) Number	K052031
Device Name	Surgeon'S Gloves
Applicant	SHUN THAI RUBBER GLOVES INDUSTRY PUBLIC CO., LTD. 198 AVENUE DE LA D'EMERALD SPARKS, NV 89434 US Other 510(k) Applications for this Company
Contact	JANNA P TUCKER Other 510(k) Applications for this Contact
Regulation Number	878.4460   More FDA Info for this Regulation Number
Classification Product Code	KGO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/27/2005
Decision Date	09/12/2005
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review