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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Surgeon'S Gloves
510(k) Number K895018
Device Name SURGICAL GLOVES
Applicant
Lon Tai Chemical Industrial Co., Ltd.
P.O. Box 4-17 Lukong
Changhua Taiwan 50606,  TW
Applicant Contact CHI (MS.)
Correspondent
Lon Tai Chemical Industrial Co., Ltd.
P.O. Box 4-17 Lukong
Changhua Taiwan 50606,  TW
Correspondent Contact CHI (MS.)
Regulation Number878.4460
Classification Product Code
KGO  
Date Received08/08/1989
Decision Date 02/16/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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