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Surgical Face Mask (HNFM0103)

FDA 510(k)

Class II (US FDA 510(k))

510(k) K221838

by Shanghai Hua En Industrial Co Ltd

Identifiers

510(k) Number
K221838 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 (HNFM0103) is a medical device classified under surgical apparel, designed to provide a physical barrier to protect both the wearer and the surrounding environment from potential contaminants during surgical procedures. It functions as a disposable face covering commonly used in clinical settings to maintain hygiene and reduce the risk of infection transmission.

This device is intended for single-use in surgical and clinical environments, supplied by Shanghai Hua EN Industrial Co, Ltd. It is regulated under 21 CFR 878.4040 as a Class II medical device and received FDA 510(k) clearance under the traditional review pathway. The product is associated with the general and plastic surgery advisory committee and is cleared for substantially equivalent use under the K221838 determination.

Frequently asked questions

What is the Surgical Face Mask (HNFM0103) used for?

It is designed to act as a physical barrier protecting both the wearer and the surrounding environment from potential contaminants during surgical procedures. It is commonly used in clinical settings to maintain hygiene and reduce the risk of infection transmission.

Is the HNFM0103 mask reusable or disposable?

It is intended for single-use in surgical and clinical environments. After one use, it should be disposed of according to local medical waste guidelines to ensure hygiene and safety.

Who manufactures the HNFM0103 Surgical Face Mask?

The device is manufactured by Shanghai Hua EN Industrial Co, Ltd., located at #30, No988 Hui Ji Rd., Xuanqiao Town, Pudong, Shanghai, China. The company is listed as the applicant for the regulatory filing.

What regulatory classification does the HNFM0103 mask have?

It is regulated under 21 CFR 878.4040 as a Class II medical device. It received FDA 510(k) clearance under the traditional review pathway with the K221838 determination, showing substantial equivalence.

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: Surgical Face Mask (HNFM0103) (K221838) — FDA 510 (k) | Innolitics, Surgical Face Mask (HNFM0103) - FDA 510(k) K221838, K221838 FDA 510(k) - Surgical Face Mask (HNFM0103), Shanghai Hua EN Industrial Co, Ltd. FDA 510(k) Products 2022

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Shanghai Hua En Industrial Co Ltd
FDA Applicant
Shanghai Hua EN Industrial Co, Ltd.

Sources (1)

  • FDA 510(k) K221838 24 fields · synced Oct 6, 2026