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FDA 510(k) Application Details - K103602
Device Classification Name
Latex Patient Examination Glove
More FDA Info for this Device
510(K) Number
K103602
Device Name
Latex Patient Examination Glove
Applicant
MEDLINE INDUSTRIES, INC.
ONE MEDLINE PLACE
MUNDELEIN, IL 60060-4486 US
Other 510(k) Applications for this Company
Contact
MATT CLAUSEN
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
12/08/2010
Decision Date
04/21/2011
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
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