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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Latex Patient Examination Glove
510(k) Number K892919
Device Name LATEX DISPOSABLE EXAMINATION GLOVES
Applicant
Union Industrial Co., Ltd.
8380 Camino Santa Fe
San Diego,  CA  92121
Applicant Contact THOMAS TRIMBLE
Correspondent
Union Industrial Co., Ltd.
8380 Camino Santa Fe
San Diego,  CA  92121
Correspondent Contact THOMAS TRIMBLE
Regulation Number880.6250
Classification Product Code
LYY  
Date Received04/12/1989
Decision Date 06/07/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
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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