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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 K221454
Device Name Disposable Medical Nitrile Examination Gloves - Non Sterile
Applicant
Guangzhou Kangling Biotechnology Co., Ltd.
Baiyun Ave.,Yongping St.,Baiyun District,Guangzhou City
East Side Of H Bldg.,# 10 E
Guangzhou,  CN 510440
Applicant Contact Yan Wang
Correspondent
Cnmed Consulting
31 Archer St.
Upper Mount Gravatt,  AU 4122
Correspondent Contact Johnson Liu
Regulation Number880.6250
Classification Product Code
LZA  
Date Received05/19/2022
Decision Date 07/12/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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