Cleared Special

K261949 - NYES Tuff Cuff L3 Disposable Gowns

K261949 is an FDA 510(k) clearance for NYES Tuff Cuff L3 Disposable Gowns, manufactured by New York Embroidery Studio. The device is a Class 2 General Hospital device with product code FYA cleared through the Special 510(k) pathway after a 29-day FDA review.

K261949 · New York Embroidery Studio · General Hospital
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Jul 2026
Decision
29d
Days
Class 2
Risk

K261949 is an FDA 510(k) clearance for the NYES Tuff Cuff L3 Disposable Gowns. Classified as Gown, Surgical (product code FYA), Class II - Special Controls.

Submitted by New York Embroidery Studio (Brooklyn, US). The FDA issued a Cleared decision on July 10, 2026 after a review of 29 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 878.4040 - the FDA general hospital device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all New York Embroidery Studio devices

FDA 510(k) Submission Details - K261949

510(k) Number K261949 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 11, 2026
Decision Date July 10, 2026
Days to Decision 29 days
Submission Type Special
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
100d faster than avg
Panel avg: 129d · This submission: 29d
Pathway characteristics
Modification to existing cleared device. 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

Medical Device Academy, Inc.
Rob Packard

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 212
Devices cleared under the same product code (FYA) and FDA review panel - the closest regulatory comparables to K261949.
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 · Principle & Will Co., Ltd. · Aug 2026
Surgical Gown Level2 (S, M, L, XL, XXL, XXXL)
K261028 · Yadu Medical (Henan) Co., Ltd. · Aug 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.