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Surgical Face Mask F-Y1-A

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K202794

by Jiande Chaomei Daily Chemicals Co., Ltd.

Identifiers

510(k) Number
K202794 FDA 510(k)
FDA Product Code
FXX FDA 510(k)

Classification

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

The Surgical Face Mask F-Y1-A is a disposable medical device designed to protect healthcare personnel and patients from airborne contaminants during surgical and clinical procedures. Classified under the product code FXX, it provides a barrier against droplets and particulate matter, ensuring a sterile field and reducing the risk of infection transmission in operating rooms and medical settings.

This device is supplied as a single-use item, intended for one-time use per patient encounter. It is manufactured by Jiande Chaomei Daily Chemicals Co., Ltd. and has received FDA 510(k) clearance under the Traditional pathway, with a decision date of December 13, 2021. The mask adheres to regulatory standards for surgical applications and is intended for use in environments requiring controlled sterility, such as hospitals and surgical centers.

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.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Jiande Chaomei Daily Chemicals Co., Ltd.

Sources (2)

  • FDA 510(k) K202794 24 fields · synced Oct 6, 2026
  • EUDAMED 1 fields · synced May 19, 2026