Cleared Traditional

K211809 - Surgical Gown

K211809 is an FDA 510(k) clearance for Surgical Gown, manufactured by Wuhan Dymex Healthcare Co., Ltd.. The device is a Class 2 General Hospital device with product code FYA cleared through the Traditional 510(k) pathway after a 129-day FDA review.

K211809 · Wuhan Dymex Healthcare Co., Ltd. · General Hospital
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Oct 2021
Decision
129d
Days
Class 2
Risk

K211809 is an FDA 510(k) clearance for the Surgical Gown. Classified as Gown, Surgical (product code FYA), Class II - Special Controls.

Submitted by Wuhan Dymex Healthcare Co., Ltd. (Wuhan, CN). The FDA issued a Cleared decision on October 18, 2021 after a review of 129 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 Wuhan Dymex Healthcare Co., Ltd. devices

FDA 510(k) Submission Details - K211809

510(k) Number K211809 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 11, 2021
Decision Date October 18, 2021
Days to Decision 129 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
At panel average
Panel avg: 129d · This submission: 129d
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 Consultant

Mid-Link Consulting Co, Ltd.
Diana Hong

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 161
Devices cleared under the same product code (FYA) and FDA review panel - the closest regulatory comparables to K211809.
Unico Global level 3 Surgical Gown (Film-reinforced SMS), Unico Global Level 3 Surgical Gown (PP+PE)
K203539 · Unicoglobal, Inc. · Dec 2021
Cardinal Health RoyalSilk Surgical Gown, Cardinal Health RoyalSilk Scrub Nurse Gown
K211765 · Cardinal Health, LLC · Nov 2021
Surgical Gown
K211509 · Hubei Wanli Protective Products Co., Ltd. · Oct 2021
Surgical Gown
K211077 · Wujiang Tutaike Textiles & Finishing Co., Ltd. · Oct 2021
Disposable Surgical Gowns
K202532 · Anhui Medpurest Medical Technology Co.,Ltd · Aug 2021
Disposable Surgical Gown
K210510 · Shandong Zhushi Pharmaceutical Group Co., Ltd. · Aug 2021