Surgical Face Mask is 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.

Device Description

The proposed device is a three-layer, single-use, flat-pleated mask. The inner and outer layers of the mask are made of polypropylene non-woven fabric, and the middle layer is made of polypropylene melt-blown fabric. The ear loops, which are made of nylon and spandex, are held in place over the users' mouth and nose by two elastic ear loops welded to the mask. The nose clip is to allow the user to fit the facemask around their nose, which is made of polypropylene and iron wire.

AI/ML Overview

The provided text is a 510(k) Summary for a Surgical Face Mask. It details the non-clinical tests performed to demonstrate the device meets acceptance criteria and is substantially equivalent to a predicate device.

Here's the information requested, based on the provided document:

1. A table of acceptance criteria and the reported device performance

The document references ASTM F2100-2019 Level 2 requirements as the acceptance criteria for several performance parameters.

Acceptance Criteria (ASTM F2100 Level 2)	Reported Device Performance (Proposed Device K202904)
Fluid Resistance: Pass at 120 mmHg	Pass at 120 mmHg
Particulate Filtration Efficiency (PFE): ≥ 98% at 0.1µm	Average 98.74% at 0.1µm
Bacterial Filtration Efficiency (BFE): ≥ 98%	Average 99.65%
Differential Pressure: < 5.0 mmH₂O/cm²	Average 4.6 mmH₂O/cm²
Flammability: Class 1	Class 1
Cytotoxicity: No cytotoxicity	No Cytotoxicity
Sensitization: No Sensitization	No Sensitization
Irritation: No Irritation	No Irritation

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document does not specify the sample sizes used for each non-clinical test.
The data provenance is from Jiangxi Feilikang Medical Technology Co., Ltd. in China. These are non-clinical test results, implying a prospective nature of testing specifically for this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This section is not applicable as the document describes non-clinical performance testing of a physical medical device (surgical face mask), not an AI/software device that requires expert-established ground truth for image interpretation or diagnosis. The "ground truth" here is established by standardized laboratory testing methods.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

This is not applicable as the document describes non-clinical performance testing of a physical medical device, not a study involving human readers or AI output adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This is not applicable. The document explicitly states: "No clinical study is included in this submission." This submission relies on non-clinical performance testing to demonstrate substantial equivalence, not a clinical study involving human readers or AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable. The device is a physical surgical face mask, not an algorithm or AI.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the non-clinical tests is established by standardized laboratory test methods and international standards (e.g., ASTM, ISO). For example, bacterial filtration efficiency is measured using a biological aerosol of Staphylococcus aureus as per ASTM F2101-2019.

8. The sample size for the training set

This is not applicable. The product is a physical medical device (surgical face mask) undergoing non-clinical performance testing, not a machine learning model that requires a training set.

9. How the ground truth for the training set was established

This is not applicable for the same reason as point 8.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

January 21, 2021

Jiangxi Feilikang Medical Technology Co., Ltd. % Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O. Box. 120-119 Shanghai, 200120 China

Re: K202904

Trade/Device Name: Surgical Face Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: September 23, 2020 Received: September 29, 2020

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.

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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 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 and Part 809); 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 (OS) 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

For CAPT Elizabeth Claverie, M.S. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality 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)

Device Name Surgical Face Mask

Indications for Use (Describe)

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:

1. Date of Preparation: 01/15/2021
1. Sponsor Identification

Jiangxi Feilikang Medical Technology Co., Ltd. Building 8, Anyuan Electronic Industry Park, Pingxiang City, Jiangxi Province, China.

Establishment Registration Number: 3017247636.

Contact Person: Shijun Zhang Position: Chairman Tel: +86-799-2181 777 Email: Keller@midbluegroup.com

1. Designated Submission Correspondent
  Ms. Diana Hong (Primary Contact Person) Ms. Jing Cheng (Alternative Contact Person)

Mid-Link Consulting Co., Ltd.

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

Tel: +86-21-22815850, Fax: +1-360-925-3199 Email: info@mid-link.net

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1. Identification of Proposed Device Trade Name: Surgical Face Mask Common Name: Surgical Face Mask Size: 17.5cm×9.5cm
  Regulatory Information Classification Name: Mask, Surgical Classification: II; Product Code: FXX; Regulation Number: 21CFR 878.4040 Review Panel: General Hospital

Indication for use:

Device Description:

1. Identification of Predicate Devices
  Predicate Device 510(k) Number: K173062 Product Name: Non-Woven Face Mask

6. Non-Clinical Test Conclusion

Non clinical tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device complies with the following standards:

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;

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A ASTM F1886/F1886M-16 Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection;
ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration;
A ASTM F88/F88M-15 Standard Test Method for Seal Strength of Flexible Barrier Materials;
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 F2101-2019 Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus;
A 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);
16 CFR Part 1610 Standard for the Flammability of Clothing Textiles;
EN 14683: 2019 Medical face masks- Requirements and test methods
ISO 10993-7:2008 Biological Evaluation of Medical Device- Part 7: Ethylene Oxide Sterilization Residuals
1. Clinical Test Conclusion

No clinical study is included in this submission.

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1. Summary of Technological characteristics

ITEM	Proposed Device K202904	Predicate Device K173062	Remark
Product Code	FXX	FXX	Same
Regulation No.	21 CFR 878.4040	21 CFR 878.4040	Same
Class	II	II	Same
Indication for Use	Surgical Face Mask is intendedfor single use by operating roompersonnel and other generalhealthcare workers to protect bothpatients and healthcare workersagainst transfer ofmicroorganisms, blood and bodyfluids, and particulate materials.	Non-Woven Face Mask (Models:VQN0185W (ear loop) andVQN0185B (ties)) is intended forsingle use by operating roompersonnel and other generalhealthcare workers to protect bothpatients and healthcare workersagainst transfer of microorganisms,blood and body fluids, andparticulate materials.	Same
Mask style	Flat-pleated, 3 layers	Flat-pleated, 3 layers	Same
Design feature	Ear loop	Ear loop/Tie-on	Different
Color	Blue	Blue	Same
Dimension	Mask Body:17.5cm×9.5cmNose Clip: 10.5cmEar Loop: 17cm	Mask Body:17.5cm×9.5cmNose Clip: UnknownEar Loop: Unknown	Similar
ASTMF2100Level	Level 2	Level 2	Same
Sterilization	Sterile	Non-Sterile	Different
Use	Single Use, Disposable	Single Use, Disposable	Same
Fluid resistance	Pass at 120mmHg	Pass at 120mmHg	Same
Particulatefiltration efficiency	Average 98.74% at 0.1µm	Average 99.74% at 0.1µm	Different
Bacterial filtrationefficiency	Average 99.65%	Average 99.4%	Different
Differentialpressure	Average 4.6mmH2O/cm²	Average 2.7mmH2O/cm²	Different
Flammability	Class 1	Class 1	Same
Label/Labeling	Complied with 21 CFR part 801	Complied with 21 CFR part 801	Same
Patient Contacting Material
Outer facing layer	Polypropylene Non-Woven Fabric	Spun-bond polypropylene	Different
Middle layer	Polypropylene Melt-Blown Fabric	Melt blown polypropylene filter
Inner facing layer	Polypropylene Non-Woven Fabric	Spun-bond polypropylene
nose clip	Polypropylene and Iron Wire	Malleable aluminum wire
Ear loop	Nylon and Spandex	Polyester
Biocompatibility
Cytotoxicity	No Cytotoxicity	No Cytotoxicity	Same
Sensitization	No Sensitization	No Sensitization	Same
Irritation	No Irritation	No Irritation	Same

Table 1 Comparison of Surgical Face Mask

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Different - Design feature

The design feature for the proposed device is ear loop type, which can be covered with that for the predicate device, namely ear loop type and tie-on type. In addition, both ear loop type and tie-on type are designed to secure the mask to the user's mouth and nose, which will not affect the indication for use and will not cause safety problems. Thus, difference in design feature will not affect the safety and effectiveness of the proposed device.

Similar - Dimension

The dimension of the proposed device is the same as that of the predicate device, and the proposed device details the dimensions of the nose clip and ear loop. Therefore, this difference does not affect the safety and effectiveness of the proposed device.

Different - Sterilization

The final product status of the proposed device is different from predicate device, one is sterilized and the other is non-sterilized. Sterilization will affect the safety and effective of the mask. The performance testing of the proposed device has been conducted on the final product and the test results show that the proposed sterile mask meets the requirements of ASTM F2100-2019. And biocompatibility testing of the proposed device has also been conducted on the final product and the test results showed that there are no negative impacts from the materials that are used in the proposed sterile mask. Therefore, although there differences between the proposed device and predicate device, the differences do not raise the issue of safety and effectiveness of the proposed device.

Different - Particulate filtration efficiency

The test result for particulate efficiency for the proposed device is different from predicate device. However, the test result for the proposed device can meet the requirements of level 2 mask. Thus, this difference does not affect the safety and effectiveness of the proposed device.

Different - Bacterial filtration efficiency

The test result for bacteria efficiency for the proposed device is different from predicate device. However, the test result for the proposed device can meet the requirements of level 2 mask. Thus, this difference does not affect the safety and effectiveness of the proposed device.

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K202904

Different - Differential pressure

The test result for different pressure for the proposed device is different from predicate device. However, the test result for the proposed device can meet the requirements of level 2 mask. Thus, this difference does not affect the safety and effectiveness of the proposed device.

Different - Patient Contacting Material

The patient contacting material for the proposed device is different from predicate device. However, biocompatibility test has been performed on the proposed device and the results does not show any adverse effect. Thus, this difference in materials will not affect the safety and effectiveness of the proposed device.

Conclusion 9.

The conclusion drawn from the non-clinical tests demonstrates that the subject device in 510(k) submission K202904, the Surgical Face Mask is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K173062.

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.