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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 K222442
Device Name DISPOSABLE VINYL EXAMINATION GLOVES (Pink, Black, Blue)
Applicant
Anhui Bytech Medical Supplies Co., Ltd.
Lingbi Economic Development Zone(North)
Suzhou City,  CN 234200
Applicant Contact Lijun Chen
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 Received08/12/2022
Decision Date 09/28/2022
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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