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Non Reinforced Surgical Gowns, Film Reinforced Surgical Gowns, Fabric Reinforced Surgical Gowns

by GRI Medical & Electronic Technology Co., Ltd.

510(k) K102652

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) K102652↗

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 NumberK102652 Date3 Feb 2011ClearedStatusActive
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  • Withdrawn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 product comprises three types of surgical gowns designed to provide barrier protection during surgical procedures. The non-reinforced gowns offer basic fluid resistance, while the film and fabric reinforced variants incorporate additional layers for enhanced durability and strength, ensuring compliance with surgical standards for contamination control.

The gowns are intended for single-use in sterile surgical environments and are classified under the FDA’s Product Code FYA. They are supplied in sterile packaging and must be stored in a clean, dry area away from direct sunlight. Authorised under FDA 510K clearance and MDR compliance, these gowns meet regulatory requirements for surgical attire in general and plastic surgery settings.

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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 surgical gowns are included in this product line, and how do they differ in terms of protection and durability?

    This product line includes three types of surgical gowns: non-reinforced, film-reinforced, and fabric-reinforced. The non-reinforced gowns provide basic fluid resistance, suitable for standard surgical procedures. The film-reinforced and fabric-reinforced gowns feature additional layers—film or fabric—for enhanced durability and strength, ensuring better protection against contamination during surgical procedures.

  • Are these gowns intended for reuse, or are they designed for single-use only?

    These gowns are explicitly designed for single-use in sterile surgical environments. They are supplied in sterile packaging to ensure safety and hygiene for each procedure, preventing cross-contamination.

  • What storage conditions should be followed to maintain the sterility and integrity of these gowns?

    The gowns must be stored in a clean, dry area away from direct sunlight to preserve their sterility and prevent degradation. Proper storage ensures the gowns remain effective for their intended single-use application.

  • What regulatory pathways have these gowns undergone, and what does that mean for their use in surgical settings?

    These gowns have undergone FDA 510(k) clearance and comply with the Medical Device Regulation (MDR). The FDA’s Product Code FYA classification and the advisory committee review under General and Plastic Surgery categories confirm their compliance with surgical attire standards, ensuring they meet regulatory requirements for use in surgical environments.