FDA 510(k) Application Details - K974371

Device Classification Name	Latex Patient Examination Glove   More FDA Info for this Device
510(K) Number	K974371
Device Name	Latex Patient Examination Glove
Applicant	CLK INTL., INC. 28 EAST BROADWAY, 2ND FL. NEW YORK, NY 10002 US Other 510(k) Applications for this Company
Contact	GEORGE Q KUO Other 510(k) Applications for this Contact
Regulation Number	880.6250   More FDA Info for this Regulation Number
Classification Product Code	LYY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/20/1997
Decision Date	04/21/1998
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