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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Latex Patient Examination Glove
510(k) Number K894751
Device Name CARIBBEAN LATEX PRODUCTS EXAMINATION GLOVES
Applicant
Caribbean Latex Products, Inc.
8353 NW 54th St.
Miami,  FL  33166
Applicant Contact SERGIO E OCHOA
Correspondent
Caribbean Latex Products, Inc.
8353 NW 54th St.
Miami,  FL  33166
Correspondent Contact SERGIO E OCHOA
Regulation Number880.6250
Classification Product Code
LYY  
Date Received07/26/1989
Decision Date 11/21/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
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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