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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 K905012
Device Name STERILE SURGICAL GLOVES/DOUBLE GLOVER
Applicant
American Advisors, Inc.
430 Sandshore Rd.
Unit #6
Hackettstown,  NJ  07840
Applicant Contact STEPHEN A WOINICKI
Correspondent
American Advisors, Inc.
430 Sandshore Rd.
Unit #6
Hackettstown,  NJ  07840
Correspondent Contact STEPHEN A WOINICKI
Regulation Number878.4460
Classification Product Code
KGO  
Date Received11/06/1990
Decision Date 12/21/1990
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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