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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 K850635
Device Name ANSELL NO POWDER SURGEON'S GLOVES
Applicant
Ansell, Inc.
Industrial Rd.
Post Office Box 1252
Dothan,  AL  36302
Applicant Contact BRADLEY L PUGH
Correspondent
Ansell, Inc.
Industrial Rd.
Post Office Box 1252
Dothan,  AL  36302
Correspondent Contact BRADLEY L PUGH
Regulation Number878.4460
Classification Product Code
KGO  
Date Received02/19/1985
Decision Date 06/26/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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