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Disposable Surgical Gowns

by Anhui Medpurest Medical Technology Co., Ltd

510(k) K202532

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 NumberK202532 Date21 Aug 2021ClearedStatusActive

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  • Withdrawn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
FDA applicant
Anhui Medpurest Medical Technology 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, 21 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 Gowns are a type of medical device used in surgical settings. They are designed to provide a barrier against bodily fluids and other contaminants, helping to prevent infection and promote a sterile environment. The gowns are made to be worn by medical professionals during surgical procedures.

The Disposable Surgical Gowns are supplied as single-use items and are intended for use in a variety of surgical settings. They are available with FDA 510K authorization and have a product code of FYA. The gowns are manufactured by Anhui Medpurest Medical Technology Co., Ltd and are distributed with a clearance type of Traditional, having been found to be substantially equivalent.

Other devices from Anhui Medpurest Medical Technology Co., Ltd

Questions

AI-generated answers, 21 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 are Disposable Surgical Gowns used for?

    They are used to provide a barrier against bodily fluids and contaminants, helping to prevent infection and promote a sterile environment during surgical procedures.

  • Are the gowns supplied as single-use or reusable items?

    The Disposable Surgical Gowns are supplied as single-use items, intended for use in a variety of surgical settings.

  • What is the regulatory status of the Disposable Surgical Gowns?

    The gowns have been authorized with FDA 510K authorization, having been found to be substantially equivalent.

  • Who manufactures the Disposable Surgical Gowns?

    The gowns are manufactured by Anhui Medpurest Medical Technology Co., Ltd.