FDA 510(k) Application Details - K063757

Device Classification Name	Surgeon'S Gloves   More FDA Info for this Device
510(K) Number	K063757
Device Name	Surgeon'S Gloves
Applicant	SHANGHAI MOTEX HEALTHCARE CO., LTD. NO. 58, FU CHIUN STREET HSIN CHU CITY 30067 TW Other 510(k) Applications for this Company
Contact	Ke-Min Jen 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	12/19/2006
Decision Date	07/27/2007
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review