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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 K043475
Device Name POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, WHITE (NON-COLORED)
Applicant
Shijiazhuang Winful Plastic Co., Ltd.
# 10b Central Rd., Avic Bld
East 3rd Ring Rd.
Chaoyang District, Beijing,  CN 10002
Applicant Contact CHEN YUHONG
Correspondent
Shijiazhuang Winful Plastic Co., Ltd.
# 10b Central Rd., Avic Bld
East 3rd Ring Rd.
Chaoyang District, Beijing,  CN 10002
Correspondent Contact CHEN YUHONG
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received12/16/2004
Decision Date 02/01/2005
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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