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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 K896881
Device Name LATEX DENTAL & EXAMINATION GLOVES
Applicant
American Intl. Health Industries P.R., Inc.
P.O. Box 1680
Canovanas,  PR  00629
Applicant Contact MIKE GOMEZ
Correspondent
American Intl. Health Industries P.R., Inc.
P.O. Box 1680
Canovanas,  PR  00629
Correspondent Contact MIKE GOMEZ
Regulation Number880.6250
Classification Product Code
LYY  
Date Received12/08/1989
Decision Date 04/25/1990
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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