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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 K043014
Device Name POWDER FREE NATURAL RUBBER LATEX PATIENT EXAMINATION GLOVES WITH LABELING PROTEIN CONTENT CLAIM (50 MICROGRAMS OR LESS)
Applicant
Shijiazhuang Tillotson Rubber Products Co., Ltd.
590 W. Central Ave.
Suite D
Brea,  CA  92821
Applicant Contact JAMES CHU
Correspondent
Shijiazhuang Tillotson Rubber Products Co., Ltd.
590 W. Central Ave.
Suite D
Brea,  CA  92821
Correspondent Contact JAMES CHU
Regulation Number880.6250
Classification Product Code
LYY  
Date Received11/02/2004
Decision Date 01/28/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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