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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 K894908
Device Name LATEX PATIENT EXAMINATION GLOVES
Applicant
Shanghai Shen Hua Rubber and Plastics Co. , Ltd.
# 89 Qi Kin Rd.
Xin Zhuang, 201100
Shanghai, China,  CN
Applicant Contact SHI RONG
Correspondent
Shanghai Shen Hua Rubber and Plastics Co. , Ltd.
# 89 Qi Kin Rd.
Xin Zhuang, 201100
Shanghai, China,  CN
Correspondent Contact SHI RONG
Regulation Number880.6250
Classification Product Code
LYY  
Date Received08/01/1989
Decision Date 10/27/1989
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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