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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Polymer Patient Examination Glove
510(k) Number K211860
Device Name Powder Free Nitrile Patient Examination Gloves, Blue Color
Applicant
Anhui Powerguard Technology Co., Ltd.
Lingbi Economic Development Zone (North)
Suzhou,  CN 234200
Applicant Contact Nick Dai
Correspondent
Beijing Easy-Link Company
Rm. F302 Bldg., 41, Jing Cheng Ya Ju, Ct.yard 6 Of
Southern Dou Ge Zhuang,Chaoyang District
Beijing,  CN 100121
Correspondent Contact Chu Xiaoan
Regulation Number880.6250
Classification Product Code
LZA  
Date Received06/16/2021
Decision Date 08/13/2021
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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