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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 K893695
Device Name PATIENT EXAM GLOVES(MFG: SHANGHAI HUA LING LAT FAC
Applicant
Shanghai Industrial Investment Co. , Ltd.
173-174 Gloucester Rd.
Hong Kong,  HK
Applicant Contact LIANG REN-QI
Correspondent
Shanghai Industrial Investment Co. , Ltd.
173-174 Gloucester Rd.
Hong Kong,  HK
Correspondent Contact LIANG REN-QI
Regulation Number880.6250
Classification Product Code
LYY  
Date Received05/16/1989
Decision Date 09/13/1989
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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