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Standard Procedure Mask, Standard Surgical Mask (K202605)

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K202605Ref A3006

by JiangSu MedPlus Non-Woven Manufacturer Co., Ltd

Identity

Trade Name
Standard Procedure Mask EUDAMED
Device Name
Standard Surgical Mask EUDAMED
Model / Reference
A3006 EUDAMED

Identifiers

Primary DI / UDI-DI
06971705240739 EUDAMED
Basic UDI-DI
697170524mask01FG EUDAMED
510(k) Number
K202605 FDA 510(k)
FDA Product Code
FXX FDA 510(k)
EMDN Code
T020604 MEDICAL USE FACE MASKS, TYPE II AND IIR EUDAMED

Classification

Device Class
Class I EUDAMED
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 878.4040 FDA 510(k)
Regulation Number
878.4040 FDA 510(k)
Market of Registration
Germany EUDAMED
Advisory Committee
General, Plastic Surgery FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Clinical & Handling

Sterile

No

EUDAMED

Implantable

No

EUDAMED

Reusable

No

EUDAMED

Contains Latex

No

EUDAMED

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

The Standard Procedure Mask, Standard Surgical Mask is classified as a surgical mask under the FDA’s Product Code FXX, designed to provide barrier protection against liquid splashes and large-particle aerosols. It is intended for use in surgical and medical procedures where infection control is critical, adhering to standards such as EN 14683:2019 for basic weight and performance requirements.

This device is supplied as a single-use, non-sterile disposable mask, intended for one-time use per patient encounter. It is regulated under FDA 510(k) clearance (K202605) and the EU Medical Device Regulation (MDR), with a basic weight specification referenced in technical documentation. Storage should follow manufacturer guidelines to maintain integrity, and it is not intended for reuse or sterilisation.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Standard Procedure Mask, Standard Surgical Mask (K202605) — FDA 510 (k ..., Jiangsu Medplus Non-woven Manufacturer Co., Ltd. - eunagyker.hu, Standards Applicable to Groups, Standard Procedure Mask, Standard Surgical Mask — FDA K202605

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
JiangSu MedPlus Non-Woven Manufacturer Co., Ltd
FDA Applicant
Jiangsu Medplus Non-Woven Manufacturer Co., Ltd.

Sources (2)

  • FDA 510(k) K202605 24 fields · synced Oct 6, 2026
  • EUDAMED 8a6da093-ca61-4016-b023-5143c30cbe08 61 fields · synced Jun 20, 2026