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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 K882715
Device Name STERILE SURGICAL LATEX GLOVES
Applicant
Plastic Materials of Puerto Rico, Inc.
P.O. Box 540
Rd. #187 - Km. 7.4
Loiza, Puerto Rico, 
Applicant Contact MIKE GOMEZ
Correspondent
Plastic Materials of Puerto Rico, Inc.
P.O. Box 540
Rd. #187 - Km. 7.4
Loiza, Puerto Rico, 
Correspondent Contact MIKE GOMEZ
Regulation Number878.4460
Classification Product Code
KGO  
Date Received07/01/1988
Decision Date 11/08/1988
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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