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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 K892103
Device Name PATIENT EXAMINATION GLOVES (LATEX)
Applicant
Jenq Chuam Industrial Co., Ltd.
# 837-1, Chung Ho St.
Hsin Seh Shiang
Taichung Hsien, Taiwan,  TW
Applicant Contact LIAN-CHI JAN
Correspondent
Jenq Chuam Industrial Co., Ltd.
# 837-1, Chung Ho St.
Hsin Seh Shiang
Taichung Hsien, Taiwan,  TW
Correspondent Contact LIAN-CHI JAN
Regulation Number880.6250
Classification Product Code
LYY  
Date Received04/03/1989
Decision Date 05/22/1989
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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