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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Vinyl Patient Examination Glove
510(k) Number K900152
Device Name POLY PATIENT EXAMINATION GLOVES
Applicant
Shanghai Strong Plastic Products Co., Ltd.
Dongjing Town, Songjiang
County
Shanghai, China,  CN
Applicant Contact HUI TANG
Correspondent
Shanghai Strong Plastic Products Co., Ltd.
Dongjing Town, Songjiang
County
Shanghai, China,  CN
Correspondent Contact HUI TANG
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received01/11/1990
Decision Date 03/08/1990
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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