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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 K142771
Device Name Xuanye Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)
Applicant
Xuanhua Metallurgical Industry CO., LTD
Bridge North, Weisan Rd, East Ring Rd, High-Tec District
Zhangjiakou,  CN 075000
Applicant Contact Yanlong Dong
Correspondent
Beijing Easylink CO.,LTD
Rm. F302 Bldg., 41, Jing Cheng Ya Ju,
Courtyard 6 of Southern Dou Ge Zhuang
Beijing,  CN 100121
Correspondent Contact Chu Xiaoan
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received09/25/2014
Decision Date 12/22/2014
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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