Cleared Traditional

K220528 - Surgical Isolation Cover Gown

K220528 is an FDA 510(k) clearance for Surgical Isolation Cover Gown, manufactured by Wuhan Dymex Healthcare Co., Ltd.. The device is a Class 2 General Hospital device with product code FYC cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K220528 · Wuhan Dymex Healthcare Co., Ltd. · General Hospital
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Jun 2022
Decision
106d
Days
Class 2
Risk

K220528 is an FDA 510(k) clearance for the Surgical Isolation Cover Gown. Classified as Gown, Isolation, Surgical (product code FYC), Class II - Special Controls.

Submitted by Wuhan Dymex Healthcare Co., Ltd. (Wuhan, CN). The FDA issued a Cleared decision on June 10, 2022 after a review of 106 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 - K220528

510(k) Number K220528 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 24, 2022
Decision Date June 10, 2022
Days to Decision 106 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
23d faster than avg
Panel avg: 129d · This submission: 106d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FYC Device Classification - Class 2, Special Controls

Product Code FYC Gown, Isolation, 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 - FYC Gown, Isolation, Surgical

All 33
Devices cleared under the same product code (FYC) and FDA review panel - the closest regulatory comparables to K220528.
CoverU Disposable Gown with Tape AAMI Level 4 Isolation Gown CoverU Disposable Gown with Tape - Chemo Gown
K210414 · Medtecs (Taiwan) Corp. · Oct 2022
AAMI4 Isolation Gown
K214116 · Hubei Xinxin Non-Woven Co., Ltd. · Oct 2022
Isolation Gown (S, M, L, XL, XXL (Yellow, Blue))
K221027 · Allmed Medical (Hubei) Protective Products Co., Ltd. · Aug 2022
AAMI3 Isolation Gown
K213832 · Hubei Xinxin Non-Woven Co., Ltd. · May 2022
Disposable Surgical Isolation Gown
K212422 · Crown Name Disposable Hygiene Products Fty., Ltd. · Apr 2022
Flosteril Poly-reinforced Isolation Gowns Model 8120 (Catalogue Number 8120400), Flosteril Poly-reinforced Isolation Gowns Model (Catalogue Number 8120410), Flosteril Poly-reinforced Isolation Gowns Model (Catalogue Number 8120430), Flosteril Poly-reinforced Isolation Gowns Model (Catalogue Number 8120450), Flosteril Poly-reinforced Isolation Gowns Model (Catalogue Number 8120460)
K210148 · Flomak Tekstil Makine Muh. Mum. Taah. San. Tic. Ltd. Sti. · Apr 2022