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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 K950468
Device Name POWDER FREE STERILE LATEX SURGEONS GLOVES
Applicant
Intl. Trade Management Co.
11321 Headlands Ct.
Reston,  VA  22091
Applicant Contact MEHUL RANDERY
Correspondent
Intl. Trade Management Co.
11321 Headlands Ct.
Reston,  VA  22091
Correspondent Contact MEHUL RANDERY
Regulation Number878.4460
Classification Product Code
KGO  
Date Received02/03/1995
Decision Date 04/25/1995
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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