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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 K211516
Device Name Disposable Vinyl Nitrile Synthetic Gloves Powder Free
Applicant
Tangshan Hongyun Plastic Products Co., Ltd.
South Shenggezhuang Village,Pachigang Town, Luannan
Tangshan,  CN 063500
Applicant Contact Suying Le
Correspondent
Shanghai Truthful Information Technology Co., Ltd.
Rm. 1801, # 161 Lujiazui E. Rd., Pudong
Shanghai,  CN 200120
Correspondent Contact Boyle Wang
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received05/17/2021
Decision Date 08/24/2021
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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