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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 K892056
Device Name SURGICAL LATEX STERILE GLOVES
Applicant
Modern Rubber Industrial Co., Ltd.
Miami Medical Equipment/Supply
1-04 SW 13th St. (Coral Way)
Miami,  FL  33130
Applicant Contact EDUARDO NOGUEIRA
Correspondent
Modern Rubber Industrial Co., Ltd.
Miami Medical Equipment/Supply
1-04 SW 13th St. (Coral Way)
Miami,  FL  33130
Correspondent Contact EDUARDO NOGUEIRA
Regulation Number878.4460
Classification Product Code
KGO  
Date Received03/24/1989
Decision Date 06/08/1989
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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