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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Latex Patient Examination Glove
510(k) Number K960841
Device Name POWDER-FREE LATEX EXAM GLOVE W/HYPOALLERGENIC CLAIM
Applicant
Boston Medical Corp.
12011 Guilford Rd.
Annapolis Junction,  MD  20701
Applicant Contact TIMOTHY F HAND
Correspondent
Boston Medical Corp.
12011 Guilford Rd.
Annapolis Junction,  MD  20701
Correspondent Contact TIMOTHY F HAND
Regulation Number880.6250
Classification Product Code
LYY  
Date Received02/27/1996
Decision Date 08/15/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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