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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 K884499
Device Name LATEX SURGICAL GLOVES
Applicant
Yuli Corp., Inc.
1145 N. 500 W.
Provo,  UT  84604
Applicant Contact JAU-FEI CHEN
Correspondent
Yuli Corp., Inc.
1145 N. 500 W.
Provo,  UT  84604
Correspondent Contact JAU-FEI CHEN
Regulation Number878.4460
Classification Product Code
KGO  
Date Received10/26/1988
Decision Date 01/09/1989
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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