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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 K261028
Device Name Surgical Gown Level2 (S, M, L, XL, XXL, XXXL)
Applicant
Yadu Medical (Henan) Co., Ltd.
66 Yangze Rd., Nanpu District, Changyuan, Xinxiang,
He Nan,  CN 453400
Applicant Contact Peilong Shi
Correspondent
Yadu Medical (Henan) Co., Ltd.
66 Yangze Rd., Nanpu District, Changyuan, Xinxiang
He Nan,  CN 453400
Correspondent Contact Winnie Li
Regulation Number878.4040
Classification Product Code
FYA  
Date Received03/30/2026
Decision Date 08/07/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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