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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 K890905
Device Name DISPOSABLE NON STERILE LATEX EXAM GLOVES
Applicant
Harvest Intl. of America, Inc.
2029 Bay St., NE
St. Petersburg,  FL  33704
Applicant Contact MICHAEL J GORDON
Correspondent
Harvest Intl. of America, Inc.
2029 Bay St., NE
St. Petersburg,  FL  33704
Correspondent Contact MICHAEL J GORDON
Regulation Number880.6250
Classification Product Code
LYY  
Date Received02/27/1989
Decision Date 08/31/1989
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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