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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 K891839
Device Name LATEX EXAMINATION GLOVES
Applicant
Yeou Jih Rubber Industrial Co., Ltd.
# 40, Aly. 26, Ln. 667
Chung Shan Rd., Shen Kang
Hsiang, Taichung Hsien,  TW
Applicant Contact CHIEH LIOU
Correspondent
Yeou Jih Rubber Industrial Co., Ltd.
# 40, Aly. 26, Ln. 667
Chung Shan Rd., Shen Kang
Hsiang, Taichung Hsien,  TW
Correspondent Contact CHIEH LIOU
Regulation Number880.6250
Classification Product Code
LYY  
Date Received03/28/1989
Decision Date 06/02/1989
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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