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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 K221027
Device Name Isolation Gown (S, M, L, XL, XXL (Yellow, Blue))
Applicant
Allmed Medical (Hubei) Protective Products Co., Ltd.
#29 Dong Hu Rd., Majiadian Town, Zhijiang City, Hubei,
China
Zhijiang,  CN 443299
Applicant Contact Vince Tian
Correspondent
Shanghai Sungo Management Consulting Company Limited.
14th Floor, 1500# Century Ave.
Shanghai,  CN 200122
Correspondent Contact Ivy Wang
Regulation Number878.4040
Classification Product Code
FYC  
Date Received04/06/2022
Decision Date 08/12/2022
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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