FDA 510(k) Application Details - K980421

Device Classification Name	Polymer Patient Examination Glove   More FDA Info for this Device
510(K) Number	K980421
Device Name	Polymer Patient Examination Glove
Applicant	OMNIGRACE (THAILAND) LTD. 7815 VANDERBILT DRIVE NW NORTH CANTON, OH 44720 US Other 510(k) Applications for this Company
Contact	WILLIAM E PATTON 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	02/03/1998
Decision Date	03/13/1998
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