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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 K890651
Device Name LATEX EXAMINATION GLOVE
Applicant
Tianjin Tang GU Latex Factory
Tang Gu Zhong Xin Zhuang
Tianjin,  CN 300454
Applicant Contact DE MING
Correspondent
Tianjin Tang GU Latex Factory
Tang Gu Zhong Xin Zhuang
Tianjin,  CN 300454
Correspondent Contact DE MING
Regulation Number880.6250
Classification Product Code
LYY  
Date Received02/08/1989
Decision Date 05/31/1989
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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