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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Vinyl Patient Examination Glove
510(k) Number K052006
Device Name POWDER-FREE VINYL EXAM GLOVES
Applicant
Baoding Guanzhong Glove Co., Ltd.
10 Seton Court
Rancho Mirage,  CA  92270
Applicant Contact MARY ANN DOUCETTE
Correspondent
Baoding Guanzhong Glove Co., Ltd.
10 Seton Court
Rancho Mirage,  CA  92270
Correspondent Contact MARY ANN DOUCETTE
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received07/25/2005
Decision Date 08/03/2005
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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