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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 K904839
Device Name PATIENT EXAM GLOVES(MFG: YUNG CHIEH ENTERPRISE)
Applicant
Up TO Date, Inc.
8348 NW 66 St.
Miami,  FL  33152
Applicant Contact FOUSU CHIANG
Correspondent
Up TO Date, Inc.
8348 NW 66 St.
Miami,  FL  33152
Correspondent Contact FOUSU CHIANG
Regulation Number880.6250
Classification Product Code
LYY  
Date Received10/18/1990
Decision Date 02/12/1991
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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