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— 510(k) K260407

Name: FDA 510(k) clearance K260407
Creator: U.S. Food and Drug Administration
Published: 2026-08-26

Substantially Equivalent

Principle & Will Co., Ltd.

FDA 510(k) clearance K260407 for 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, Substantially Equivalent on 2026-08-26. Applicant: Principle & Will Co., Ltd.. Device class: 2.

Clearance details

Applicant: Principle & Will Co., Ltd.
Product code: Code FYA
Device class: Class 2
Regulation: 21 CFR 878.4040
Advisory panel: General, Plastic Surgery
Date received: 2026-02-09
Decision date: 2026-08-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Apia, WS

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