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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 K892980
Device Name LONGFORTUNE PATIENT EXAM GLOVES
Applicant
Long Fortune Industries , Ltd.
432 N. Canal St.
Suite #2
South San Francisco,  CA  94080
Applicant Contact HAIM SAMUCHA
Correspondent
Long Fortune Industries , Ltd.
432 N. Canal St.
Suite #2
South San Francisco,  CA  94080
Correspondent Contact HAIM SAMUCHA
Regulation Number880.6250
Classification Product Code
LYY  
Date Received04/12/1989
Decision Date 07/31/1989
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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