Cleared Traditional

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

K260407 is an FDA 510(k) clearance for Principle & Will ANSI/AAMI PB 70 (Steri..., manufactured by Principle & Will Co., Ltd.. The device is a Class 2 General Hospital device with product code FYA cleared through the Traditional 510(k) pathway after a 198-day FDA review.

K260407 · Principle & Will Co., Ltd. · General Hospital
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Aug 2026
Decision
198d
Days
Class 2
Risk

K260407 is an FDA 510(k) clearance for the Principle & Will ANSI/AAMI PB 70 (Sterile/Non-sterile) Level 3 Surgical Gowns.... Classified as Gown, Surgical (product code FYA), Class II - Special Controls.

Submitted by Principle & Will Co., Ltd. (Apia, WS). The FDA issued a Cleared decision on August 26, 2026 after a review of 198 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 878.4040 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Principle & Will Co., Ltd. devices

FDA 510(k) Submission Details - K260407

510(k) Number K260407 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 09, 2026
Decision Date August 26, 2026
Days to Decision 198 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized Yes - Predetermined Change Control Plan authorized FDA has pre-authorized specific future modifications to this device, a pathway common in AI/SaMD devices.
Regulatory Context
Review time vs. panel average
69d slower than avg
Panel avg: 129d · This submission: 198d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. PCCP authorized - AI/SaMD pathway.

FYA Device Classification - Class 2, Special Controls

Product Code FYA Gown, Surgical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4040
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Consultant

Principle & Will Biotech (PingHu) Co., Ltd.
Jing Ke

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - FYA Gown, Surgical

All 210
Devices cleared under the same product code (FYA) and FDA review panel - the closest regulatory comparables to K260407.
Surgical Gown Level2 (S, M, L, XL, XXL, XXXL)
K261028 · Yadu Medical (Henan) Co., Ltd. · Aug 2026
NYES Tuff Cuff L3 Disposable Gowns
K261949 · New York Embroidery Studio · Jul 2026
Tuff Cuff™ Disposable Surgical Gowns AAMI L4 Sterile-Large (ML-L4-STL-DC-L)
K252575 · New York Embroidery Studio (NYES) · Jun 2026
BAÜMER Surgical Gowns (COP01, COP04, COP05, COP10)
K260725 · Hindernis DE Mexico, S.A.P.I. DE C.V. · May 2026
Cardinal Health™ Poly Reinforced Surgical Gown
K253243 · Cardinal Health 200, LLC · Apr 2026
Non-sterile Level 3 Surgical Gown (4025)
K253003 · Hubei Xinxin Non-Woven Co., Ltd. · Apr 2026

FDA 510(k) Resources - General Hospital

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.