Cleared Traditional

Surgical gowns (K212718) - FDA 510(k) Clearance

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

K212718 · Xiantao Dingcheng Non-Woven Product Co., Ltd. · General Hospital
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Jan 2022
Decision
138d
Days
Class 2
Risk

K212718 is an FDA 510(k) clearance for the Surgical gowns. Classified as Gown, Surgical (product code FYA), Class II - Special Controls.

Submitted by Xiantao Dingcheng Non-Woven Product Co., Ltd. (Xiantao, CN). The FDA issued a Cleared decision on January 12, 2022 after a review of 138 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 Xiantao Dingcheng Non-Woven Product Co., Ltd. devices

Submission Details

510(k) Number K212718 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 27, 2021
Decision Date January 12, 2022
Days to Decision 138 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
9d slower than avg
Panel avg: 129d · This submission: 138d
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

Shanghai Truthful Information Technology Co., Ltd.
Boyle Wang

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 105
Devices cleared under the same product code (FYA) and FDA review panel - the closest regulatory comparables to K212718.
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Disposable Surgical Gown
K212591 · Suzhou Janee Medical Technology Co., Ltd. · Jan 2022
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Surgical Gown, Reinforced Surgical Gown
K212861 · Wuhan Zonsen Medical Products Co., Ltd. · Dec 2021