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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 K893163
Device Name PATIENT EXAMINATION GLOVES
Applicant
Nantong Ruchang Latex Products Co., Ltd.
Huna Zhen
Rudong County, Jiangsu
China,  CN
Applicant Contact WU WENHAN
Correspondent
Nantong Ruchang Latex Products Co., Ltd.
Huna Zhen
Rudong County, Jiangsu
China,  CN
Correspondent Contact WU WENHAN
Regulation Number880.6250
Classification Product Code
LYY  
Date Received04/14/1989
Decision Date 08/10/1989
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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