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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Polymer Patient Examination Glove
510(k) Number K011717
Device Name SUNMAX BLUE NITRILE POWDERED EXAMINATION GLOVES
Applicant
Sunmax Enterprise Shanghai Co. , Ltd.
55 Northern Blvd., Suite 200
Great Neck,  NY  11021
Applicant Contact SUSAN D GOLDSTEIN-FALK
Correspondent
Sunmax Enterprise Shanghai Co. , Ltd.
55 Northern Blvd., Suite 200
Great Neck,  NY  11021
Correspondent Contact SUSAN D GOLDSTEIN-FALK
Regulation Number880.6250
Classification Product Code
LZA  
Date Received06/04/2001
Decision Date 08/14/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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