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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 K223280
Device Name Disposible Nitrile Gloves
Applicant
Holik Asia Group Co.,Ltd
#18 Nanyi Rd.,Xuanzhou Economic Development Zone,Liqiao
Town,Xuanzhou District
Xuancheng,  CN 242000
Applicant Contact Monica Zhou
Correspondent
Shanghai Spica Management Consulting Co., Ltd.
609 Rm., # 133 Shengang Ave., Pudong New District
Shanghai,  CN 201306
Correspondent Contact Libray Chang
Regulation Number880.6250
Classification Product Code
LZA  
Date Received10/24/2022
Decision Date 05/08/2023
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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