Disposable Medical Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. It is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device(s), provided as sterile.

Device Description

The Disposable Medical Mask consists of a mask body, a nose piece, and ear loops or ties. The mask body is divided into four layers, the inner, second and outer layers are made of polypropylene materials; the middle layer is composed of melt-blown cloth (polypropylene); the nose piece is made of galvanized iron wire, the ear loops are made of polyester and spandex, and the ties are made of polypropylene. The Medical Surgical Mask will be provided in green. The Disposable Medical Mask is sold as sterile and are intended to be single use, disposable devices.

AI/ML Overview

This document primarily details the non-clinical testing and substantial equivalence determination for a Disposable Medical Mask (K222545) in comparison to a predicate device (K211454). It is not a study that proves a device meets acceptance criteria through a clinical or reader study involving human interpretation of AI results.

This submission is for a medical mask, which is a physical device, and the "acceptance criteria" discussed are primarily related to its physical and biological performance characteristics (e.g., filtration efficiency, fluid resistance, biocompatibility), not the performance of an AI algorithm. Therefore, many of the requested points, such as those related to AI algorithm performance, human expert adjudication, MRMC studies, and ground truth establishment for AI training/testing, are not applicable to this document.

However, I can extract the relevant information regarding the acceptance criteria and performance of the mask itself based on the provided text.

Acceptance Criteria and Device Performance (Applicable to the physical mask device)

The document details the performance testing of the Disposable Medical Mask against established standards.

1. Table of Acceptance Criteria and Reported Device Performance

Item	Purpose	Acceptance Criteria	Reported Device Performance (Results)
Synthetic Blood Penetration (ASTM F1862)	Demonstrate resistance to liquid penetration	Level 3 pass at 160mmHg (AQL 4%)	Pass (32 out of 32 pass at 160 mmHg)
Particulate Filtration Efficiency (ASTM F2299)	Demonstrate particulate filtration	Level 3 pass at ≥98%	Pass (Filtration Efficiency ≥ 99.80%)
Bacterial Filtration Efficiency (ASTM F2101)	Demonstrate bacterial filtration	Level 3 pass at ≥98%	Pass (Percent BFE ≥ 99.80%)
Differential Pressure (Delta P) (EN 14683 Annex C)	Demonstrate breathability	Level 3 pass at ≤ 6.0 mmH2O/cm²	Pass (Average 4.2 mm H2O/cm²)
Flammability (16 CFR 1610)	Demonstrate flame resistance	Class I	Pass
Cytotoxicity	Biocompatibility	Non-cytotoxic	Pass (Non-cytotoxic)
Irritation	Biocompatibility	Non-irritating	Pass (Non-irritating)
Sensitization	Biocompatibility	Non-sensitizing	Pass (Non-sensitizing)

2. Sample size used for the test set and the data provenance:

Synthetic Blood Penetration: 32 samples (stated as "32 out of 32 pass at 160 mmHg"). For acceptance, it states "29 samples out of 32 pass (AQL 4%)".
Other performance tests (Particulate Filtration Efficiency, Bacterial Filtration Efficiency, Differential Pressure, Flammability, Biocompatibility): Specific sample sizes are not explicitly stated for each test, but standard test methods (e.g., ASTM, ISO) typically specify the number of samples required.
Data Provenance: Not explicitly stated as retrospective or prospective given this is laboratory testing of a physical product. The manufacturer is Guangzhou Fuzelong Hygiene Material Co., Ltd, China.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. This document describes laboratory performance testing of a physical medical device (a mask), not the evaluation of an AI algorithm's diagnostic performance requiring human expert ground truth. The "ground truth" here is the objective measurement of the mask's physical properties against defined standards.

4. Adjudication method for the test set:

Not applicable. See point 3.

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:

No. This is not an AI device.

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

No. This is not an AI device.

7. The type of ground truth used:

The "ground truth" for the mask's performance is based on objective measurements against pre-defined international and national standards (e.g., ASTM, EN, ISO, 16 CFR). For example, "Level 3 pass at ≥98%" for filtration efficiency is the acceptance criterion acting as the "ground truth."

8. The sample size for the training set:

Not applicable. This is not an AI device that requires a "training set."

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

Not applicable. See point 8.

Summary

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May 19, 2023

Guangzhou Fuzelong Hygiene Material Co., Ltd % Boyle Wang Correspondent Shanghai Truthful Information Technology Co., Ltd. RM. 1801, No. 161 Lujiazui East Rd.,Pudong Shanghai, Shanghai 200120 China

Re: K222545

Trade/Device Name: Disposable Medical Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical apparel Regulatory Class: Class II Product Code: FXX Dated: April 1, 2023 Received: April 19, 2023

Dear Boyle Wang:

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 mediation-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,

Katherine D. Kavlock -S

for

Brent Showalter, Ph.D. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K222545

Device Name Disposable Medical 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

K222545

This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR 807.92.

1.0 submitter's Information

Name: Guangzhou Fuzelong Hygiene Material Co., Ltd Address: #12, Guancun Road, Jiangpu Street, Conghua, Guangzhou, China 510900 Tel:+86-020-87993188 Contact: Haiyan Zeng Date of Preparation: Aug.12, 2022

Designated Submission Correspondent

Mr. Boyle Wang Shanghai Truthful Information Technology Co., Ltd. Room 1801, No. 161 East Lujiazui Rd., Pudong, Shanghai 200120, China Tel: +86-21-50313932 Email: Info@truthful.com.cn

2.0 Device Information

Trade name: Disposable Medical Mask Common name: Surgical Face Mask Classification name: Surgical Face Mask Model: Ear loops, Tie-on

3.0 Classification

FXX - Mask, Surgical. Production code: Classification Name: Surgical Apparel (21 CFR part 878.4040) Classification: Class II Panel: Surgical Apparel

4.0 Predicate Device Information

Manufacturer:	Jiangsu Xingtong Biotechnology Group Co., Ltd.
Device:	Surgical mask
510(k) number:	K211454

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5.0 Device Description

The Disposable Medical Mask consists of a mask body, a nose piece, and ear loops or ties.

The mask body is divided into four layers, the inner, second and outer layers are made of polypropylene materials; the middle layer is composed of melt-blown cloth (polypropylene); the nose piece is made of galvanized iron wire, the ear loops are made of polyester and spandex, and the ties are made of polypropylene.

The Medical Surgical Mask will be provided in green. The Disposable Medical Mask is sold as sterile and are intended to be single use, disposable devices.

The size specification of the surgical mask:

Mask body for ear-loop type: 14.5cm × 9cm (S), 17.5cm × 9.5cm (M), 18cm × 9.3cm (L), 22cm×9.5cm (XL);
Mask body for Tie-on type: 14.5cm X 9cm (S), 17.5cm X 9.5cm (M), 18cm X 9.3cm (L), 22cm×9.5cm (XL).

The smallest sizes mask (14.5cm×9cm) are for adult population only.

6.0 Indication for Use Statement

7.0 Comparison to the Predicate Device

Table 1 General Comparison
Item	Subject Device	Predicate DeviceK211454	Remark
Product Name	Medical Surgical Mask	Surgical mask	--
Product Code	FXX	FXX	Same
Regulation No.	21 CFR 878.4040	21 CFR 878.4040	Same
Class	II	II	Same
Intended Use&Indications for use	Medical Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. It is intended for use in infection control practices to reduce the	The surgical 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	Same
		potential exposure to bloodand body fluids. This is asingle use, disposabledevice(s), provided assterile.	reduce the potentialexposure to blood and bodyfluids. This is a single-use,disposable device, providedas sterile.
Design features		Ear Loops,Tie-on,4 layers	Ear loops: XT10A1;Tie-on: XT10B1;3 layers	DifferentAnalysis 1
Mask Styles		Flat pleated	Flat pleated	Same
Material	Outerfacinglayer	Polypropylene	Polypropylene	Same
	Middlelayer	1. Polypropylene2. Melt-blown cloth(polypropylene)	1. Melt-blown cloth(polypropylene)	Similar
	InnerFacinglayer	Polypropylene	Polypropylene	Same
	Nosepiece	Galvanized iron wire	Polyethylene coatedsteel wire	DifferentAnalysis 1
	Earloops,Ties	-Ear loops: Polyester,spandex-Ties: Polypropylene	-Ear loops: Polyester silk &Polyurethane filament-Ties: Polypropylene	SimilarAnalysis 1
Color		Green	Blue	DifferentAnalysis 2
Dimension		- Mask body for ear-looptype:14.5cm×9cm (S),17.5cm×9.5cm (M),18cm×9.3cm (L),22cm×9.5cm (XL);- Mask body for Tie-on type:14.5cm×9cm (S),17.5cm×9.5cm (M),18cm×9.3cm (L),22cm×9.5cm (XL).The smallest sizes mask(14.5cm×9cm) are for adultpopulation only.	Mask body for ear-looptype:17.5cm×9.5cm &14.5cm×9.5cmMask body for Tie-on type:17.5cm×9.5cm	DifferentAnalysis 3
OTC use		Yes	Yes	Same
Shelf life		2 years	2 years	Same
Single Use	Yes	Yes	Same
Sterility	Sterile	Sterile	Same
Sterilizationmethod andS.A.L.	Sterilized by ethyleneoxide gas, SAL=10-6	Sterilized by ethyleneoxide gas, SAL=10-6	Same
ASTM F2100 Level	Level 3	Level 3	Same

Table 1 General Comnarison

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Analysis 1: the two devices have some difference in design features and materials, product materials safety is proved by its biocompatibility, and the difference does not raise additional questions for safety and effectiveness of device.

Analysis 2: The subject device (Green) has different color to the predicate device (Blue), but all proposed devices are conducted the biocompatibility test. The difference does not raise additional questions for safety and effectiveness of device.

Analysis 3: the two devices have some difference in dimensions, the little deviation in dimensions does not raise additional questions for safety and effectiveness of device.

8.0 Non-Clinical Test Conclusion

The proposed device was tested and conformed to the following standards and the requirements stated in the Guidance for Industry and FDA Staff: Medical face masks

Premarket Notification [510(k)] Submission issued on March 5, 2004.

ISO 10993-5: 2009 Biological Evaluation of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity

ISO 10993-10: 2010 Biological Evaluation of Medical Devices - Part 10: Tests for Irritation and Skin Sensitization

ASTM F2100, Standard Specification for Performance of Materials Used in Medical Face Masks

ASTM F1862, Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at A Known Velocity);

ASTM F2101, Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) Of Medical Face Mask Materials, Using A Biological Aerosol of Staphylococcus Aureus;

ASTM F2299, stand test method for determining the initial efficiency of materials used in medical face masks to penetration by particulates using latex spheres;

16 CFR 1610, Standard for the Flammability of clothing textiles;

Item	Purpose	Acceptance Criteria	Results
Synthetic	Demonstrate	29 samples out of 32	Pass

Table 2 - Performance Testing

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BloodPenetrationASTMF1862	resistanceto liquidpenetration	pass (AQL 4%)Level 3 pass at160mmHg	32 out of 32 pass at 160mmHg
ParticulateFiltrationEfficiencyASTMF2299	Demonstrateparticulatefiltration	Level 3 pass at ≥98%	PassFiltration Efficiency (%)≥ 99.80%
BacterialFiltrationEfficiencyASTMF2101	Demonstratebacterialfiltration	Level 3 pass at ≥98%	PassPercent BFE (%)≥ 99.80%
DifferentialPressure(Delta P)EN 14683Annex C	Demonstratebreathability	Level 3 pass at ≤ 6.0mmH2O/cm²	PassAverage 4.2 mm H2O/cm²
Flammability16 CFR1610	Demonstrateflameresistance	Class I	Pass

Table 4 - Biocompatibility Testing

Item	Subject Device	Result
Cytotoxicity	Under the conditions of the study, the subject device was non-cytotoxic	Pass
Irritation	Under the conditions of the study, the subject device was non-irritating	Pass
Sensitization	Under the conditions of the study, the subject device was non-sensitizing	Pass

9.0 _Clinical Test Conclusion

No clinical study is included in this submission.

10.0 Conclusion

The conclusion drawn from the non-clinical tests demonstrates that the subject device is as safe, as effective, and performs as well as or better than the legally marketed predicate device in K211454.

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.