Cleared Traditional

Surgical Isolation Cover Gown (K220528) - FDA 510(k) Clearance

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

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

Submission Details

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.

Device Classification

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 25
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