Skip to content

Guangzhou Fortunique Drapes Bags and Covers

by Guangzhou Fortunique, Ltd.

510(k) K041501

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

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 NumberK041501 Date30 Nov 2004ClearedStatusActive

Recalls

6 recalls · 1 ongoing · FDA

    • Ongoing Z-1926-2020 FDA Class II initiated 7 Jan 2020

    Sterile drapes packaged in an unsealed pouch.

  • 3 recalls, same reason

    • Terminated Z-3234-2017 FDA Class II initiated 27 Jun 2017
    • Terminated Z-3236-2017 FDA Class II initiated 27 Jun 2017
    • Terminated Z-3235-2017 FDA Class II initiated 27 Jun 2017

    The sterile drape material may contain a pinhole compromising its integrity resulting in a breach of the sterile barrier.

  • 2 recalls, same reason

    • Terminated Z-1409-2017 FDA Class II initiated 23 Jan 2017
    • Terminated Z-1408-2017 FDA Class II initiated 23 Jan 2017

    Sterility compromised due to breach in sterile barrier

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  • Withdrawn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
MMP
FDA applicant
Guangzhou Fortunique , Ltd.
Device Class
Class II
Regulation
21 CFR Part 878.4370
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 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 cover, barrier, protective product classified under product code MMP and regulation number 878.4370. It is intended to cover equipment, maintain a sterile field, and aid in the clean up of equipment after surgery or other medical procedures.

The device is supplied by Guangzhou Fortunique, Ltd. and received FDA 510(k) clearance (K041501) on November 30, 2004, following a traditional review. It is a Class II medical device subject to special controls, with no indication of sterility, single-use or reusable status, MRI safety, sizes, or storage conditions provided in the data.

Questions

AI-generated answers, 1 Oct 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 Guangzhou Fortunique Drapes, Bags and Covers intended for?

    This device is intended to cover equipment, maintain a sterile field, and aid in the clean up of equipment after surgery or other medical procedures, as stated in its description.

  • How is the Guangzhou Fortunique Drapes, Bags and Covers supplied?

    The device is supplied by Guangzhou Fortunique, Ltd., as indicated in the manufacturer and applicant fields of the device data.

  • Is the Guangzhou Fortunique Drapes, Bags and Covers sterile, single-use, or reusable?

    The data provided does not include any indication of sterility, single-use, or reusable status for this device.

  • What regulatory pathway was used for the Guangzhou Fortunique Drapes, Bags and Covers?

    The device received FDA 510(k) clearance (K041501) on November 30, 2004, following a traditional review process, as specified in the authorizations and decision description fields.

  • What sizes or models are available for the Guangzhou Fortunique Drapes, Bags and Covers?

    No specific sizes, models, or reference numbers are provided in the device data beyond the product name and classification.