Cleared Traditional

K253003 - Non-sterile Level 3 Surgical Gown (4025) (FDA 510(k) Clearance)

Also includes:
Sterile Level 3 Surgical Gown (M4025) Non-sterile Reinforced Level 4 Surgical Gown (G4025) Reinforced Sterile Level 4 Surgical Gown (GM4025)

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K253003 · Hubei Xinxin Non-Woven Co., Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2026
Decision
213d
Days
Class 2
Risk

K253003 is an FDA 510(k) clearance for the Non-sterile Level 3 Surgical Gown (4025). Classified as Gown, Surgical (product code FYA), Class II - Special Controls.

Submitted by Hubei Xinxin Non-Woven Co., Ltd. (Xiantao, CN). The FDA issued a Cleared decision on April 20, 2026 after a review of 213 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 Hubei Xinxin Non-Woven Co., Ltd. devices

Submission Details

510(k) Number K253003 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 2025
Decision Date April 20, 2026
Days to Decision 213 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
85d slower than avg
Panel avg: 128d · This submission: 213d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 292
Devices cleared under the same product code (FYA) and FDA review panel - the closest regulatory comparables to K253003.
Cardinal Health™ Poly Reinforced Surgical Gown
K253243 · Cardinal Health 200, LLC · Apr 2026
Copioumed AAMI 3 Surgical Gown
K251860 · Copioumed International, Inc. · Feb 2026
Henan Yadu Level 4 Surgical Gowns (Reinforced)
K252301 · Yadu Medical (Henan) Co., Ltd. · Feb 2026
Surgical Gown (Level 3: S, M, L, XL, XXL, XXXL)
K250564 · Yadu Medical (Henan) Co., Ltd. · Dec 2025
ViVi® Toga Premium
K243522 · Thi Total Healthcare Innovation GmbH · May 2025
Dream Medi Sterile Surgical Gown (SurgicalGownUL)
K242937 · Dae Myung Chemical Co., Ltd. (Vietnam) · May 2025