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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Surgeon'S Gloves
510(k) Number K981947
Device Name STERILE POWDER FREE NITRILE SURGEONS GLOVES (NATURAL, BLUE AND GREEN)
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 Number878.4460
Classification Product Code
KGO  
Date Received06/03/1998
Decision Date 03/03/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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