Cleared Traditional

K222480 - Standard Surgical Gown (AAMI Level 2) (FDA 510(k) Clearance)

Also includes:
Reinforced Surgical Gown (AAMI Level 2)

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

K222480 · Foshan Nanhai Plus Medical Co, Ltd. · General Hospital
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Nov 2022
Decision
89d
Days
Class 2
Risk

K222480 is an FDA 510(k) clearance for the Standard Surgical Gown (AAMI Level 2). Classified as Gown, Surgical (product code FYA), Class II - Special Controls.

Submitted by Foshan Nanhai Plus Medical Co, Ltd. (Foshan, CN). The FDA issued a Cleared decision on November 14, 2022 after a review of 89 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Foshan Nanhai Plus Medical Co, Ltd. devices

Submission Details

510(k) Number K222480 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 17, 2022
Decision Date November 14, 2022
Days to Decision 89 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 128d · This submission: 89d
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 Consultant

Guangzhou Osmunda Medical Device Technical Service Co., Ltd.
Olivia Meng

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 292
Devices cleared under the same product code (FYA) and FDA review panel - the closest regulatory comparables to K222480.
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
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