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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 K072145
Device Name MEDICAL GLOVE SERIES
Applicant
Zhanjiang Jiali Glove Products Co., Ltd.
Suite 8d, # 19, Ln. 999
Zhongshan # 2 Rd.
Shanghai,  CN 200030
Applicant Contact Diana Hong
Correspondent
Zhanjiang Jiali Glove Products Co., Ltd.
Suite 8d, # 19, Ln. 999
Zhongshan # 2 Rd.
Shanghai,  CN 200030
Correspondent Contact Diana Hong
Regulation Number880.6250
Classification Product Code
LYY  
Subsequent Product Code
LZA  
Date Received08/02/2007
Decision Date 02/26/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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