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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 K953358
Device Name SURGEONS GLOVE POWDER FREE
Applicant
American Pro Latex, Inc.
815 Connecticut Ave., NW
Suite 1100
Washington,  DC  20006
Applicant Contact BRADFORD E KILE
Correspondent
American Pro Latex, Inc.
815 Connecticut Ave., NW
Suite 1100
Washington,  DC  20006
Correspondent Contact BRADFORD E KILE
Regulation Number878.4460
Classification Product Code
KGO  
Date Received07/17/1995
Decision Date 12/28/1995
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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