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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 K260407
Device Name Principle & Will ANSI/AAMI PB 70 (Sterile/Non-sterile) Level 3 Surgical Gowns (Reinforced) and Principle & Will ANSI/AMMI PB70 (Sterile/Non-sterile) Level 4 Surgical Gowns/Isolation Gowns
Applicant
Principle & Will Co., Ltd.
Level 2, Lotemau Centre Bldg., Vaea St., Apia, Samoa.
Apia,  WS
Applicant Contact I Chun Chuang
Correspondent
Principle & Will Biotech (PingHu) Co., Ltd.
#2000, Xingping Ii Rd., Pinghu Economic Development Zone
Jiaxing City, 314200 Zhejiang, P.R. China
Jiaxing,  CN 314200
Correspondent Contact Jing Ke
Regulation Number878.4040
Classification Product Code
FYA  
Subsequent Product Code
FYC  
Date Received02/09/2026
Decision Date 08/26/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 Yes
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