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ComfortGuard Plus Surgical Gown i500

by Gri Medical & Electrical Technology Co., Ltd.

510(k) K162442

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 NumberK162442 Date12 Dec 2016ClearedStatusActive

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  • Withdrawn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)

Full name
ComfortGuard Plus Surgical Gown, i500, ComfortGuard Surgical Gown, i500
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, 25 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 ComfortGuard Plus Surgical Gown i500 is a single-use surgical gown designed to protect surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material. It is intended for use in high-risk, sterile environments such as operating rooms, laboratories, and clinician offices.

The gown is supplied as a single-use device and is not reusable. It is not MRI safe. The device is regulated under FDA 510(k) clearance (K162442) and is intended for use in general and plastic surgery settings.

Other devices from Gri Medical & Electrical Technology Co., Ltd.

Questions

AI-generated answers, 25 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 ComfortGuard Plus Surgical Gown i500 used for?

    It is a single-use surgical gown intended for use in high-risk, sterile environments such as operating rooms, laboratories, and clinician offices to protect both surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material.

  • Is the ComfortGuard Plus Surgical Gown i500 reusable?

    No, the ComfortGuard Plus Surgical Gown i500 is supplied as a single-use device and is not reusable.

  • Is the ComfortGuard Plus Surgical Gown i500 MRI safe?

    No, the ComfortGuard Plus Surgical Gown i500 is not MRI safe.

  • What regulatory clearance does the ComfortGuard Plus Surgical Gown i500 have?

    The ComfortGuard Plus Surgical Gown i500 is regulated under FDA 510(k) clearance (K162442).