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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 K212029
Device Name Disposable Medical Nitrile Examination Gloves (non-sterile)
Applicant
Taizhou Kangjian Medical Equipments Co., Ltd.
The Machine Electricity Zone (Hang Ni Kan) Of Yuhuan County
Taizhou,  CN 317600
Applicant Contact Hua Cong
Correspondent
Cytech (Shenzhen) Enterprise Management Consulting Co., Ltd.
Rm. 302, Bldg. 3, Hangqian Mansion
Hangqian St., Lucheng District
Wenzhou,  CN 325000
Correspondent Contact Helen Nan
Regulation Number880.6250
Classification Product Code
LZA  
Date Received06/29/2021
Decision Date 11/16/2021
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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