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Disposable medical face masks

FDA UDI

Class II (US FDA UDI)

by Jiang Xi Sanxin Medtec Co., Ltd.

Identity

Trade Name
Disposable medical face masks FDA UDI
Generic Name
Surgical/medical face mask, non-antimicrobial, single-use FDA UDI
Device Name
The sterile disposable medical face masks are intended for single use by operating room personnel and other general healthcare workers to protect both patients and healthcare workers against transfer of microorganisms, blood and body fluids, and particulate materials.The non-sterile disposable medical face masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device, provided non-sterile FDA UDI
Model / Reference
Type A (ear-loop type),Large size,Sterile 9.5×17.5 Level 2 FDA UDI
Description
The sterile disposable medical face masks are intended for single use by operating room personnel and other general healthcare workers to protect both patients and healthcare workers against transfer of microorganisms, blood and body fluids, and particulate materials.The non-sterile disposable medical face masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device, provided non-sterile FDA UDI

Identifiers

Primary DI / UDI-DI
06945060520010 FDA UDI
510(k) Number
K202719 FDA UDI
FDA Product Code
FXX FDA UDI
GMDN Term
Surgical/medical face mask, non-antimicrobial, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4040 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Surgical/medical face mask, non-antimicrobial, single-use

Disposable medical face masks by Jiang Xi Sanxin Medtec Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Surgical/medical face mask, non-antimicrobial, single-use.

Cleared under the same submission

K202719 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Jiang Xi Sanxin Medtec Co., Ltd.

Sources (1)

  • FDA UDI d5d53a1b-a62f-4316-8d20-5823f845a470 34 fields · synced May 29, 2026