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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 K891667
Device Name EVERGOOD BRAND (PATIENT EXAM GLOVES-LATEX)
Applicant
San HU Chemical Industry Co., Ltd.
1250 Broadway
18th Floor
New York,  NY  10001
Applicant Contact LINDA ZHAO
Correspondent
San HU Chemical Industry Co., Ltd.
1250 Broadway
18th Floor
New York,  NY  10001
Correspondent Contact LINDA ZHAO
Regulation Number880.6250
Classification Product Code
LYY  
Date Received03/20/1989
Decision Date 08/25/1989
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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