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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gown, Isolation, Surgical
510(k) Number K223411
Device Name Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL)
Applicant
Xiamen Probtain Medical Techology Co., Ltd.
4th Floor, #1 Bldg., #6 Ji'An Rd., Tong'An District
Xiamen,  CN 361100
Applicant Contact Jianli Kang
Correspondent
Xiamen Probtain Medical Techology Co., Ltd.
4th Floor, #1 Bldg., #6 Ji'An Rd., Tong'An District
Xiamen,  CN 361100
Correspondent Contact Jianli Kang
Regulation Number878.4040
Classification Product Code
FYC  
Date Received11/09/2022
Decision Date 01/04/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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