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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 K900650
Device Name LATEX EXAMINATION GLOVES
Applicant
Shenzhen Guang JI Emulsion Products Co., Ltd.
Liantang Exploitation District
Shenzhen
China,  CN
Applicant Contact CHENG JIANG
Correspondent
Shenzhen Guang JI Emulsion Products Co., Ltd.
Liantang Exploitation District
Shenzhen
China,  CN
Correspondent Contact CHENG JIANG
Regulation Number880.6250
Classification Product Code
LYY  
Date Received02/09/1990
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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