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Disposable Surgical Gown

by Henan Robestain Medical Products Co., Ltd.

510(k) K212925

Active European Union and United States

CE MDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K212925↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, 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 510(k) Substantially Equivalent · Traditional NumberK212925 Date13 Dec 2021ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

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

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 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, 18 Sep 2026

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

This device is a Disposable Surgical Gown (FDA Product Code: FYA), a single-use protective garment designed to shield healthcare personnel and patients from contamination during surgical procedures. Constructed from fluid-resistant materials, it provides a barrier against blood, bodily fluids, and particulate matter, adhering to standards for sterile surgical environments.

The gown is supplied as a sterile, single-use item intended for use in operating rooms, surgical suites, and other controlled clinical settings. Available in standard sizes, it must be stored in a clean, dry environment to maintain sterility and integrity. Authorised under FDA 510K clearance (K212925) and MDR compliance, it complies with regulatory requirements for disposable surgical attire without MRI restrictions.

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Questions

AI-generated answers, 18 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 types of procedures is this disposable surgical gown designed to protect against contamination during?

    This disposable surgical gown is designed to shield healthcare personnel and patients from contamination during surgical procedures in controlled environments like operating rooms and surgical suites. Its fluid-resistant materials create a barrier against blood, bodily fluids, and particulate matter, ensuring protection in sterile settings where minimizing contamination risk is critical.

  • How should I store this gown to ensure it remains sterile and intact before use?

    The gown must be stored in a clean, dry environment to preserve its sterility and structural integrity. Since it is a single-use item, avoid exposing it to moisture, dust, or direct sunlight, as these conditions can compromise its protective properties before use.

  • Is this gown reusable, or is it intended for one-time use only?

    This gown is explicitly designed as a single-use item, meaning it should not be reused after one surgical procedure. The manufacturer emphasizes its disposable nature to maintain hygiene and prevent cross-contamination in clinical settings.

  • What sizes are available for this disposable surgical gown?

    The gown is supplied in standard sizes, though the exact dimensions are not detailed in the provided data. For precise sizing options, refer to the manufacturer’s packaging or technical documentation, as these are typically tailored to common adult body measurements used in surgical environments.

  • What regulatory pathways does this gown follow, and does it have any restrictions for use in medical imaging?

    This gown is authorized under both FDA 510(k) clearance (K212925) and MDR compliance, confirming its adherence to regulatory standards for disposable surgical attire. The manufacturer explicitly notes there are no MRI restrictions, meaning it can be safely used in procedures involving magnetic resonance imaging.