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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 K881664
Device Name LATEX SURGICAL GLOVE
Applicant
Lien Chang Rubber Industrial Co., Ltd.
16,Ln. 472, Sec.4,Chang Shui
Hsing Nung Vill. Pei Tu Hsiang
Chang Hua Hsien, Taiwan,  TW
Applicant Contact J. P CHEN
Correspondent
Lien Chang Rubber Industrial Co., Ltd.
16,Ln. 472, Sec.4,Chang Shui
Hsing Nung Vill. Pei Tu Hsiang
Chang Hua Hsien, Taiwan,  TW
Correspondent Contact J. P CHEN
Regulation Number878.4460
Classification Product Code
KGO  
Date Received04/18/1988
Decision Date 01/06/1989
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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