FDA 510(k) Application Details - K010830

Device Classification Name	Vinyl Patient Examination Glove   More FDA Info for this Device
510(K) Number	K010830
Device Name	Vinyl Patient Examination Glove
Applicant	GENERAL GLOVES CORP. 25 PEI MA, 16 LIN TUNG CHUNG VILLAGE, TUNG SHAN HSIANG TAINAN HSIEN 733 TW Other 510(k) Applications for this Company
Contact	JOHN CHEN Other 510(k) Applications for this Contact
Regulation Number	880.6250   More FDA Info for this Regulation Number
Classification Product Code	LYZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/20/2001
Decision Date	04/09/2001
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