K260407

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) 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. WS
Product code: FYA — Gown, Surgical
Decision date: 2026-08-26
Date received: 2026-02-09
Decision: Substantially Equivalent
Clearance type: Traditional
Advisory committee: General, Plastic Surgery

This submission filed a 510(k) Statement rather than a Summary; no public summary is available from FDA.

Official FDA record: K260407

Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.