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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 K894195
Device Name LATEX EXAMINATION GLOVES
Applicant
Jiahn Chiaur Enterprise Co., Ltd.
# 48-3,Hsin Juang Tzy,Heng
Shan Hsiang
Hsin Chu Hsien,  TW
Applicant Contact YU PENG
Correspondent
Jiahn Chiaur Enterprise Co., Ltd.
# 48-3,Hsin Juang Tzy,Heng
Shan Hsiang
Hsin Chu Hsien,  TW
Correspondent Contact YU PENG
Regulation Number880.6250
Classification Product Code
LYY  
Date Received06/14/1989
Decision Date 07/28/1989
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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