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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 K191292
Device Name Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)
Applicant
Anhui Powerguard Technology Co., Ltd.
North Development Zone, Lingbi County
Jiujiang,  CN 234200
Applicant Contact Nike Dai
Correspondent
Beijing Easylink Co., Ltd.
Rm. F302 Bldg., 41, Jing Cheng Ya Ju
Ct.yard 6 Of Southern Dou Ge Zhuang
Beijing,  CN 100021
Correspondent Contact Chu Xiaoan
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received05/14/2019
Decision Date 11/05/2019
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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