FDA 510(k) Application Details - K974114

Device Classification Name	Polymer Patient Examination Glove   More FDA Info for this Device
510(K) Number	K974114
Device Name	Polymer Patient Examination Glove
Applicant	DASH MEDICAL GLOVES SDN BHD 10180 SOUTH 54TH ST. FRANKLIN, WI 53132 US Other 510(k) Applications for this Company
Contact	ROBERT J SULLIVAN 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	10/31/1997
Decision Date	12/18/1997
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