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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 K884495
Device Name SURGICAL GLOVES
Applicant
Sanko Chemical Industry Co., Ltd.
820 Irving St.
San Francisco,  CA  94122
Applicant Contact TOKUMI NAKAHARA
Correspondent
Sanko Chemical Industry Co., Ltd.
820 Irving St.
San Francisco,  CA  94122
Correspondent Contact TOKUMI NAKAHARA
Regulation Number878.4460
Classification Product Code
KGO  
Date Received10/12/1988
Decision Date 07/14/1989
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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