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SEJONG Surgical Gown Soft

by Sejong Healthcare Co., Ltd.

510(k) K220435

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 NumberK220435 Date10 Feb 2023ClearedStatusActive

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  • Withdrawn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
FYA
Device Class
Class II
Regulation
21 CFR Part 878.4040
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 27 Sep 2026

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

The Sejong Surgical Gown Soft is a sterile, single-use surgical apparel designed to be worn by healthcare professionals. It functions as a protective barrier to help prevent the transfer of microorganisms, body fluids, and particulate matter between the patient and the healthcare worker.

Constructed from SMMMS structural fabric, this gown provides water repellency and resistance to microbial penetration, meeting the Level 3 requirements of ANSI/AAMI PB70:2012. The device is authorized under FDA 510(k) clearance K220435.

Other devices from Sejong Healthcare Co., Ltd.

Questions

AI-generated answers, 27 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 primary function of the Sejong Surgical Gown Soft?

    This gown serves as a protective barrier for healthcare professionals during surgical procedures. It is designed to minimize the transfer of microorganisms, body fluids, and particulate matter between the patient and the wearer.

  • Is the Sejong Surgical Gown Soft intended for multiple uses?

    No, this device is strictly for single-use. It is provided in a sterile state and must be disposed of after a single procedure to maintain hygiene standards and prevent cross-contamination.

  • What material is used in the construction of this gown?

    The gown is manufactured using SMMMS structural fabric. This material is specifically chosen for its water repellency and resistance to microbial penetration, allowing the gown to meet the Level 3 performance requirements defined by ANSI/AAMI PB70:2012.

  • What is the regulatory status of this surgical gown?

    The Sejong Surgical Gown Soft is authorized under FDA 510(k) clearance, specifically identified by K-number K220435. This indicates that the device has been reviewed and found to be substantially equivalent to legally marketed predicate devices.