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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 K920876
Device Name CUT RESISTANT GLOVES OR SURGICAL GLOVE LINER
Applicant
Medtech Intl., Inc.
455 Douglass Ave.
Suite 2155-30
Altamonte Springs,  FL  32714
Applicant Contact BRIAN LEMAY
Correspondent
Medtech Intl., Inc.
455 Douglass Ave.
Suite 2155-30
Altamonte Springs,  FL  32714
Correspondent Contact BRIAN LEMAY
Regulation Number878.4460
Classification Product Code
KGO  
Date Received02/26/1992
Decision Date 12/11/1992
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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