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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 K091661
Device Name POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
Applicant
Zhang Jia Gang Huayuan Plastic Co. , Ltd.
Rm. 1606 Bldg. 1, Jianxiang Yuan # 209
Bei Si Huan Zhong Rd.
Haidian Dis, Beijing,  CN 100083
Applicant Contact CHU XIAOAN
Correspondent
Zhang Jia Gang Huayuan Plastic Co. , Ltd.
Rm. 1606 Bldg. 1, Jianxiang Yuan # 209
Bei Si Huan Zhong Rd.
Haidian Dis, Beijing,  CN 100083
Correspondent Contact CHU XIAOAN
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received06/09/2009
Decision Date 07/27/2009
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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