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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 K880632
Device Name PROTEQ SURGEON'S GLOVES
Applicant
Strategic Materials Group
2040 N. Loop W.
P.O. Box 920919
Houston,  TX  77292
Applicant Contact A. E ARFSTEN
Correspondent
Strategic Materials Group
2040 N. Loop W.
P.O. Box 920919
Houston,  TX  77292
Correspondent Contact A. E ARFSTEN
Regulation Number878.4460
Classification Product Code
KGO  
Date Received02/16/1988
Decision Date 03/31/1988
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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