FDA 510(k) Application Details - K011198

Device Classification Name	Polymer Patient Examination Glove   More FDA Info for this Device
510(K) Number	K011198
Device Name	Polymer Patient Examination Glove
Applicant	MAXXIM MEDICAL, INC. 10300 49TH ST. NORTH CLEARWATER, FL 33762 US Other 510(k) Applications for this Company
Contact	JAMAL S ALNASER 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	04/19/2001
Decision Date	05/17/2001
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	Y
Expedited Review