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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 K022091
Device Name BALDUR BRAND VINYL POWDER-FREE EXAMINATION GLOVES
Applicant
Tangshan Zhonghong Pulin Group Co., Ltd.
33235 Transit Ave.
Union City,  CA  94587
Applicant Contact DAVID HU
Correspondent
Tangshan Zhonghong Pulin Group Co., Ltd.
33235 Transit Ave.
Union City,  CA  94587
Correspondent Contact DAVID HU
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received06/27/2002
Decision Date 12/30/2002
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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