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The Tracker / August 2026 / K260407

510(k) cleared

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

Principle & Will Co., Ltd. · Aug 26, 2026 · K260407

FDA cleared the 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 from Principle & Will Co., Ltd. on Aug 26, 2026 under K260407, a traditional 510(k). The device falls under product code FYA, Gown, Surgical, regulated at 21 CFR 878.4040 as a Class 2 device. The review panel was General, Plastic Surgery.

FDA logged the submission as received on Feb 9, 2026. The decision came 198 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Principle & Will Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260407?

K260407 is the FDA 510(k) 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, submitted by Principle & Will Co., Ltd.. FDA's decision date was Aug 26, 2026, under product code FYA (Gown, Surgical).

Who makes the 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?

Principle & Will Co., Ltd., based in Apia, is the applicant of record for K260407.

How long did the K260407 review take?

FDA received the submission on Feb 9, 2026 and issued its decision on Aug 26, 2026, 198 days later.

← All decisions in August 2026