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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 K892064
Device Name LATEX SURGICAL GLOVES,STERILE/NON STERILE MOD BRAN
Applicant
Modern Rubber Industrial Co., Ltd.
P.O. Box 81-778
Taipei, Taiwan
Republic Of China,  CN
Applicant Contact Y. C CHENG
Correspondent
Modern Rubber Industrial Co., Ltd.
P.O. Box 81-778
Taipei, Taiwan
Republic Of China,  CN
Correspondent Contact Y. C CHENG
Regulation Number878.4460
Classification Product Code
KGO  
Date Received03/30/1989
Decision Date 04/26/1989
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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