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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 K894090
Device Name PATIENT EXAMIN GLOVES(MFG: SHANGHAI FACTORY)
Applicant
Everbest Machinery (U.S.A.) Co. , Ltd.
6474 Corvett St.
Commerce,  CA  90040
Applicant Contact GOING-FEN DAI
Correspondent
Everbest Machinery (U.S.A.) Co. , Ltd.
6474 Corvett St.
Commerce,  CA  90040
Correspondent Contact GOING-FEN DAI
Regulation Number880.6250
Classification Product Code
LYY  
Date Received06/09/1989
Decision Date 04/16/1990
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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