Cleared Traditional

K261028 - Surgical Gown Level2 (S, M, L, XL, XXL, XXXL)

K261028 is an FDA 510(k) clearance for Surgical Gown Level2 (S, manufactured by Yadu Medical (Henan) Co., Ltd.. The device is a Class 2 General Hospital device with product code FYA cleared through the Traditional 510(k) pathway after a 130-day FDA review.

K261028 · Yadu Medical (Henan) Co., Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2026
Decision
130d
Days
Class 2
Risk

K261028 is an FDA 510(k) clearance for the Surgical Gown Level2 (S, M, L, XL, XXL, XXXL). Classified as Gown, Surgical (product code FYA), Class II - Special Controls.

Submitted by Yadu Medical (Henan) Co., Ltd. (He Nan, CN). The FDA issued a Cleared decision on August 7, 2026 after a review of 130 days - within the typical 510(k) review window.

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 Yadu Medical (Henan) Co., Ltd. devices

FDA 510(k) Submission Details - K261028

510(k) Number K261028 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 2026
Decision Date August 07, 2026
Days to Decision 130 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
1d slower than avg
Panel avg: 129d · This submission: 130d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 Peers - FYA Gown, Surgical

All 210
Devices cleared under the same product code (FYA) and FDA review panel - the closest regulatory comparables to K261028.
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K253003 · Hubei Xinxin Non-Woven Co., Ltd. · Apr 2026