Disposable Face Mask

• K Number: K202905
• Device Name: Disposable Face Mask
• Manufacturer: Jiangsu Excellence Medical Supplies Co., Ltd
• Date Cleared: 2021-03-26 ( 178 days)
• Product Code: FXX
• Regulation Number: 878.4040

Intended Use

The Disposable Face Mask is 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.

Device Description

The proposed device, Disposable Face Mask is a three-layer, single-use, flat-pleated mask. The ear loops to secure the mask over the users' mouth and face and includes a nosepiece to provide a firm fit over the nose. The disposable surgical mask is available in four different specifications: 14.5cmx9.5cm and 17.5cmx9.5cm. The device is single use and provided non-sterile.

Predicate Devices

K160269

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the physical properties and filtration capabilities of a disposable face mask, with no mention of AI or ML.

Therapeutic

No.
The device description and intended use clearly state that the Disposable Face Mask is for protection from transfer of microorganisms and particulates, and for infection control practices, not for treating a disease or condition.

Diagnostic

No

The device description clearly states its purpose is to protect from transfer of microorganisms, body fluids, and particulate material, which is a protective function, not a diagnostic one.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a physical, three-layer face mask with ear loops and a nosepiece, indicating it is a hardware device. There is no mention of software functionality.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use is to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material by being worn on the face. This is a physical barrier function.
• Device Description: The device is a physical mask designed to be worn.
• Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This face mask does not interact with or analyze any such specimens.

The function of this device is to act as a physical barrier, which falls under the category of personal protective equipment (PPE) and medical devices used for infection control, not in vitro diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Disposable Face Mask is 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.

Product codes

FXX

Device Description

The proposed device, Disposable Face Mask is a three-layer, single-use, flat-pleated mask. The ear loops to secure the mask over the users' mouth and face and includes a nosepiece to provide a firm fit over the nose. The disposable surgical mask is available in four different specifications: 14.5cmx9.5cm and 17.5cmx9.5cm. The device is single use and provided non-sterile.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

healthcare personnel

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Non-clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:

• ASTM F1862/F1862M-17 Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity)
• ASTM F2299/F2299M-03(2017) Standard Test Method for Determining the Initial Efficiency of Material Used in medical Face Masks to Penetration by Particulates using Latex Spheres
• ASTM F2101-19 Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of A Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus
• ISO 10993-5:2009 Biological evaluation of medical device- Part 5: Tests for in vitro cytotoxicity
• ISO 10993-10:2010 Biological evaluation of medical device- Part 10: Tests for irritaion and skin sensitization
  No clinical study is included in this submission.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

• Fluid resistance: Level 1 Pass at 80mmHg, Level 2 Pass at 120mmHg
• Particulate efficiency level ASTM F2299: ≥95%, ≥98%
• Bacterial filtration level ASTM F2101: ≥95%, ≥98%
• Differential pressure EN 14683:

Regulation Number and Section

§ 878.4040 Surgical apparel.

(a)
Identification. Surgical apparel are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Examples include surgical caps, hoods, masks, gowns, operating room shoes and shoe covers, and isolation masks and gowns. Surgical suits and dresses, commonly known as scrub suits, are excluded.(b)
Classification. (1) Class II (special controls) for surgical gowns and surgical masks. A surgical N95 respirator or N95 filtering facepiece respirator is not exempt if it is intended to prevent specific diseases or infections, or it is labeled or otherwise represented as filtering surgical smoke or plumes, filtering specific amounts of viruses or bacteria, reducing the amount of and/or killing viruses, bacteria, or fungi, or affecting allergenicity, or it contains coating technologies unrelated to filtration (e.g., to reduce and or kill microorganisms). Surgical N95 respirators and N95 filtering facepiece respirators are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9, and the following conditions for exemption:(i) The user contacting components of the device must be demonstrated to be biocompatible.
(ii) Analysis and nonclinical testing must:
(A) Characterize flammability and be demonstrated to be appropriate for the intended environment of use; and
(B) Demonstrate the ability of the device to resist penetration by fluids, such as blood and body fluids, at a velocity consistent with the intended use of the device.
(iii) NIOSH approved under its regulation.
(2) Class I (general controls) for surgical apparel other than surgical gowns and surgical masks. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.

Summary

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March 26, 2021

Jiangsu Excellence Medical Supplies Co., Ltd % Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O.box 120-119 Shanghai. 200120 China

Re: K202905

Trade/Device Name: Disposable Face Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: February 25, 2021 Received: February 26, 2021

Dear Diana Hong:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal

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statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Ryan Ortega PhD Acting Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K202905

Device Name

Disposable Face Mask

Indications for Use (Describe)

The Disposable Face Mask is 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.

Type of Use (Select one or both, as applicable)

] Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92. The

assigned 510(k) Number: K202905

• 1. Date of Preparation: 03/26/2020
• 2. Sponsor Identification

Jiangsu Excellence Medical Supplies Co., Ltd.

No.65 Huiling West Road, Zouqu Town, Zhonglou District, Changzhou City, Jiangsu Province, 203144, China

Establishment Registration Number: 3010138147

Contact Person: Jing Zhu Position: General Manager Tel: [phone] Fax: [phone] Email:[e-mail]

• 3. Designated Submission Correspondent
     Ms. Diana Hong (Primary Contact Person) Ms. Tingting Su (Alternative Contact Person)

Mid-Link Consulting Co., Ltd.

P.O. Box 120-119, Shanghai, 200120, China

Tel: [phone], Fax: [phone] Email: [e-mail]

• 4. Identification of Proposed Device
     Common Name: Surgical Mask Trade Name: Disposable Face Mask Models: 14.5cm×9.5cm(L1), 17cm×9.5cm(L1), 17.5cm×9.5cm(L1) 14.5cm×9.5cm(L2), 17cm×9.5cm(L2), 17.5cm×9.5cm(L2)

Regulatory Information Classification Name: Mask, Surgical

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Classification: II; Product Code: FXX; Regulation Number: 21CFR 878.4040 Review Panel: General Hospital

Indication for use:

The Disposable Face Mask is intended to be worn to protect both the patient and healthcare persomel 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.

Device Description:

The proposed device, Disposable Face Mask is a three-layer, single-use, flat-pleated mask. The ear loops to secure the mask over the users' mouth and face and includes a nosepiece to provide a firm fit over the nose. The disposable surgical mask is available in four different specifications: 14.5cmx9.5cm and 17.5cmx9.5cm. The device is single use and provided non-sterile.

• 5. Identification of Predicate Device
     510(k) Number: K160269 Product Name: Surgical Face Masks (Ear loops and Tie-on) Models: EL 10000, EL 10010, TO 10000, TO 10010 EL 20000, EL 20010, TO 20000, TO 20010

EL 30000, EL 30010, TO 30000, TO 30010

• Comparison of technological characteristics between the subject and predicate devices 6.

ITEM	Proposed Device K202905	Predicate Device K160269	Remark
Product Code	FXX	FXX	Identical
Regulation No.	21 CFR 878.4040	21 CFR 878.4040	Identical
Class	II	II	Identical
Indication for Use	The Disposable Face Mask is
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.	The surgical 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.	Same
Mask style	Flat pleated	Flat pleated	Identical

Table 1 Comparison of Disposable Face Mask

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Design feature	Ear strap		Ear strap/ Tie-on		Same
Dimension	145mm×95mm,		175mm×90mm,		Similar
	170mm×95mm,		180mm×90mm
	175mm×95mm
ASTM F2100 Level	Level 1		Level 1		Identical
	Level 2		Level 2		Identical
Fluid resistance	Level 1 Pass	at 80mmHg	Level 1 Pass	at 80mmHg	Identical
ASTM F1862	Level 2 Pass	at 120mmHg	Level 2 Pass	at 120mmHg	Identical
Particulate efficiency
level ASTM F2299	≥95%	≥98%	Pass at 99.6%	Pass at 99.6%	Similar
Bacterial filtration
level ASTM F2101	≥95%	≥98%	Pass at >98%	Pass at >98%	Similar
Differential pressure
EN 14683	$ ASTM F2299/F2299M-03(2017) Standard Test Method for Determining the Initial Efficiency of Material Used in medical Face Masks to Penetration by Particulates using Latex Spheres

• ASTM F2101-19 Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of A Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus

• ISO 10993-5:2009 Biological evaluation of medical device- Part 5: Tests for in vitro cytotoxicity

• ISO 10993-10:2010 Biological evaluation of medical device- Part 10: Tests for irritaion and skin sensitization

• Clinical Test Conclusion 8.

No clinical study is included in this submission.

Substantially Equivalent (SE) Conclusion 9.

The conclusion drawn from the nonclinical tests demonstrates that the subject device in 510(K) submission K202905, the Disposable Face Mask is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K160269.