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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gown, Surgical
510(k) Number K211422
Device Name Level 2 Standard Surgical Gown, Level 3 Standard Surgical Gown, Level 3 Reinforced Surgical Gown
Applicant
Jiangsu Medplus Non-Woven Manufacturer Co., Ltd.
#217 E. Wencheng Rd., Economic Development Zone
Siyang,  CN 223700
Applicant Contact Shuying An
Correspondent
Mid-Link Consulting Co, Ltd.
P.O.Box 120-119
Shanghai,  CN 200120
Correspondent Contact Diana Hong
Regulation Number878.4040
Classification Product Code
FYA  
Date Received05/07/2021
Decision Date 07/02/2021
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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