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Surgical Isolation Cover Gown

by Wuhan DYMEX Healthcare Co., Ltd

510(k) K220528

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK220528 Date10 Jun 2022ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
FYC
FDA applicant
Wuhan Dymex Healthcare Co., Ltd.
Device Class
Class II
Regulation
21 CFR Part 878.4040
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 26 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

A Surgical Isolation Cover Gown is a device intended to provide barrier protection in healthcare settings. It is classified as a Class 2 medical device under FDA regulations.

The gown is supplied non-sterile and is intended for single-use. It has received FDA 510(k) clearance (K220528) through the traditional pathway and is manufactured by Wuhan DYMEX Healthcare Co., Ltd.

Other devices from Wuhan DYMEX Healthcare Co., Ltd

See all devices from Wuhan DYMEX Healthcare Co., Ltd →

Questions

AI-generated answers, 26 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Surgical Isolation Cover Gown used for?

    The Surgical Isolation Cover Gown is intended to provide barrier protection in healthcare settings, helping to reduce the risk of exposure to fluids and microorganisms during medical procedures.

  • Is the Surgical Isolation Cover Gown sterile or non-sterile, and is it reusable?

    The gown is supplied non-sterile and is designed for single-use only; it should not be reprocessed or reused, as doing so may compromise its barrier integrity and increase contamination risk.

  • What regulatory pathway was used for the Surgical Isolation Cover Gown, and what is its clearance number?

    The device received FDA 510(k) clearance through the traditional pathway, with clearance number K220528, and was found substantially equivalent to a predicate device.