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Disposable Surgical Gown Rk-3011C

by Xiantao Rhycom Non-Woven Products Co., Ltd.

510(k) K211060

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 NumberK211060 Date28 Oct 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  • Withdrawn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
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, 22 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 Disposable Surgical Gown Rk-3011C is a surgical apparel device intended to be worn by operating room personnel during surgical procedures to protect the surgical patient and operating room personnel from the transfer of microorganisms and body fluids. It is classified as a Class II device under the regulation 21 CFR 878.4040. The device is used to provide a barrier against microorganisms and fluids, helping to prevent infection and contamination.

The Disposable Surgical Gown Rk-3011C is supplied as a disposable, single-use device. It has been cleared under the FDA 510(k) clearance with the reference number K211060. The device is manufactured by Xiantao Rhycom Non-Woven Products Co., Ltd and has a product code of FYA. It is available in a specific model, Rk-3011C.

Questions

AI-generated answers, 22 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 Rk-3011C Surgical Gown used for?

    The Rk-3011C Surgical Gown is used to provide a barrier against microorganisms and fluids, helping to prevent infection and contamination during surgical procedures.

  • Is the Rk-3011C Surgical Gown reusable?

    No, the Rk-3011C Surgical Gown is supplied as a disposable, single-use device, intended to be used once and then discarded.

  • What is the regulatory status of the Rk-3011C Surgical Gown?

    The Rk-3011C Surgical Gown has been cleared under the FDA 510(k) clearance with the reference number K211060, indicating it is substantially equivalent to a predicate device.

  • Who manufactures the Rk-3011C Surgical Gown?

    The Rk-3011C Surgical Gown is manufactured by Xiantao Rhycom Non-Woven Products Co., Ltd.