Medical mask is intended for use by healthcare workers during procedures to protect both patients and healthcare workers against transfer of microorganisms, bodily fluids, and particulate materials. This device is single-use and provided non-sterile.

Device Description

The Medical mask are four-layer, flat-folded masks constructed of nonwoven polypropylene materials. The mask is provided with ear loops (polyester and polyurethane), and a malleable nosepiece which is placed within the binding for comfort and individualized fit. The mask not made with latex materials, and all materials are being used in currently marketed devices. The mask will be provided in white. The masks are single-use, disposable devices, provided non-sterile.

AI/ML Overview

The provided document is a 510(k) Premarket Notification for a Medical Mask (Model: KKF-1A). It focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance and biocompatibility testing, rather than an AI-powered medical device.

Therefore, many of the requested details about acceptance criteria and study design for an AI/ML device (e.g., sample size for AI test/training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, type of ground truth) are not applicable to this document. The document describes a traditional medical device (a mask) and standard testing for physical properties and biological safety.

However, I can extract the acceptance criteria and performance data for the medical mask based on the provided tables.

Acceptance Criteria and Reported Device Performance for the Medical Mask (Model: KKF-1A)

Item (Performance Test)	Acceptance Criteria for Level 1 (ASTM F2100-19)	Reported Device Performance (Test Results)
Fluid Resistance Performance (mmHg) ASTM F1862	29 out of 32 pass at 80 mmHg	Passed at 80 mmHg
Particulate Filtration Efficiency Performance (%) ASTM F2299	≥ 95%	Passed at 99.3%
Bacterial Filtration Efficiency Performance (%) ASTM F2101	≥ 95%	Passed at 98.1%
Differential Pressure (Delta-P) (mm H2O/cm²) MIL-M-36954C	< 5.0 mm H2O/cm²	Passed at 4.8 mm H2O/cm²
Flammability class Class 1 (16 CFR 1610)	Class 1	Class 1

Biocompatibility Testing Summary (based on ISO 10993-1: 2018)

Test Item	Acceptance Criteria (Implied: Non-cytotoxic, Non-irritating, Non-sensitizing)	Reported Device Performance (Result)
Cytotoxicity	Non-cytotoxic	PASS (non-cytotoxic)
Irritation	Non-irritating	PASS (non-irritating)
Sensitization	Non-sensitizing	PASS (non-sensitizing)

Since this document pertains to a physical medical mask rather than an AI/ML device, the following points are not present or not applicable in the provided text:

Sample sized used for the test set and the data provenance: Not applicable. These are physical tests on the mask material, not an AI test set.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as ground truth is established via standardized physical and chemical tests, not expert consensus on medical images or outcomes.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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: Not applicable. This is for AI-assisted diagnostic devices.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The ground truth here is the results of standardized physical and chemical tests as per ASTM, EN, and ISO standards (e.g., specific filtration percentages, pressure values, and biological reaction classifications).
The sample size for the training set: Not applicable. This is not an AI/ML device.
How the ground truth for the training set was established: Not applicable.

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). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

March 3, 2021

Han Zhaoqing Sporting Goods Company Limited % Cassie Lee Manager Share Info (Guangzhou) Medical Consultant LTD Contact Address

Re: K202316

Trade/Device Name: Medical mask (Model: KKF-1A) Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: January 15, 2021 Received: January 15, 2021

Dear Cassie Lee:

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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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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 (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 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,

For 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 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) K202316

Device Name Medical mask (Model: KKF-1A)

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 summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92.

Subject Device: Medical mask (Model: KKF-1A) 510(k) Number: K202316

1. Submitter's Information

510(k) Owner's Name: Han Zhaoqing Sporting Goods Company Limited Establishment Registration Number: 3016690756 Address: NO.2-1, Kang tai Street, High-tech zone, Zhaoqing City, Guangdong Province, P.R.China Trade Mark: KOUMASK™ Post Code: 526238 Contact name: Zhang Ming Tel: +86- 138 2551 8595 E-mail: info@koumask.co

Application Correspondent:

Contact Person: Ms. Cassie Lee Guangzhou GLOMED Biological Technology Co., Ltd. Address: 2231, Building 1, Rui Feng Center, Kaichuang Road, Huangpu District, Guangzhou, Guangdong, China Tel: +86 20 8266 2446 Email: regulatory@glomed-info.com

2. Date of the summary prepared date: August 11, 2020

3. Revision date: February 23, 2021

4. Subject Device Information

Type of 510(k): Traditional Trade Name: Medical mask Model Name: KKF-1A Common Name/Regulation Description: Surgical apparel Classification Name: Mask, Surgical Review Panel: General Hospital Product Code: FXX Regulation Number: 878.4040 Requlation Class: II

5. Predicate Device Information Predicate Device:

Sponsor: Protect U Guard, LLC. Trade Name: Protect U Guard Earloop and Tie-On Mask (Blue, White or Green) Common Name/Regulation Description: Surgical apparel Classification Name: Mask, Surgical

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510(K) Number: K153409 Review Panel: General Hospital Product Code: FXX Regulation Number: 878.4040 Regulation Class: II

6. Device Description

7. Intended Use / Indications for Use

8. Comparison to predicate device and conclusion

The differences between the subject device and predicate devices do not raise new issues of safety or effectiveness.

Elements ofComparison	Subject Device	Predicate Device	Comparison
Company	Han Zhaoqing Sporting GoodsCompany Limited	Protect U Guard, LLC.	--
510 (k)	K202316	K153409	--
Trade Name	Medical mask	Protect U Guard Earloop andTie-On Mask (Blue, White, orGreen)	--
Classification Name	Mask, Surgical	Mask, Surgical	Same
Classification	Class II	Class II	Same
Product Code	FXX	FXX	Same
Indication for Use	Medical mask is intended for useby healthcare workers duringprocedures to protect bothpatients and healthcare workersagainst transfer ofmicroorganisms, bodily fluids, andparticulate materials. This deviceis single-use and provided non-sterile.	Earloop Mask and Tie-OnMask is intended for use byhealthcare workers duringprocedures to protect bothpatients and healthcareworkers against transfer ofmicroorganisms, bodily fluids,and airborne particles. Thisdevice is single-use andprovided non-sterile.	Same
Intendedpopulations	Adult only	Adult only	Same
Materials
Outer facinglayer	Spunbound Polypropylene	Spunbound Polypropylene	Same
Middle filter layer	-Melt blown polypropylene	Melt blown Polypropylene	Similar
Elements ofComparison	Subject Device	Predicate Device	Comparison
	-Polypropylene		Note 1
Inner facinglayer	Spunbound Polypropylene	Spunbound Polypropylene	Same
Nose clip	Polyethylene coated steel wire	Aluminum strip	Same
Ear loops	Polyester	Urethane Elastic Fiber	SameNote 1
Design features	Color: White,Ear loops,Flat Pleated	Earloop or Tie-On FlatPleated	SimilarNote 1
Mask Style	Flat-pleated	Earloop or Tie-On FlatPleated	Same
Dimensions	16cm x 10.5cm (±0.5cm)	9.5cm x 17.7 cm	SimilarNote 1
OTC use	Yes	Yes	Same
Sterility	Non-Sterile	Non-Sterile	Same
Use	Single Use, Disposable	Single Use, Disposable	Same
PerformanceTesting	Level 1 (ASTM F2100-19)	Level 1 (ASTM F2100)	SameNote 2
Fluid ResistancePerformance	Pass at 80 mm Hg(F1862/F1862M - 17)	Pass at 80 mm Hg(F1862/F1862M)	Same
Particulate FiltrationEfficiency	99.3% at 0.1 micron(F2299/F2299M – 03 (2017))	99.18% at 0.1 micron (ASTMF2299/F2299M – 03 (2010))	SimilarNote 2
Bacterial FiltrationEfficiency	Pass at 98.1% (ASTM F2101-19)	99.17% (ASTM F2101-14)	SimilarNote 2
Differential Pressure	4.8 mm H2O/cm² (EN 14683:2019, Annex C)	3.79 mm H2O/cm² (MIL-M-36954C)	SimilarNote 2
Flammability	Class 1 (16 CFR 1610)	Class 1 (16 CFR 1610)	Same
Biocompatibility
Cytotoxicity(ISO 10993-5)	Under the conditions of the study,the subject device was non-cytotoxic.	Under the conditions of thestudy, the device is non-cytotoxic.	Same
Irritation(ISO 10993-10)	Under the conditions of the study,the subject device was non-irritating.	Under the conditions of thestudy, the device is non-irritating.	Same
Sensitization(ISO 10993-10)	Under the conditions of the study,the subject device was non-sensitizing	Under the conditions of thestudy, the device is non-sensitizing.	Same

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Comparison in Detail(s): Note 1:

Although the "Ear loops", "Design features", "Dimensions" and "Middle filter layer" of subject device is a little difference with predicate devices, but the subject device met the performance test and ISO 10993 standards required. So, the differences between the subject devices and predicate devices will not affect the safety and effectiveness.

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Note 2:

Although the "Particulate Filtration Efficiency", "Bacterial Filtration Efficiency" and "Performance Testing" of subject device is little difference from predicate devices, but they all met the requirements of the same standard, and subject device is based on the up to date version of standards, which is better. So, the differences between the subject device and predicate devices will not affect the safety and effectiveness.

Note 3:

Although the "Differential Pressure" of subject device is little difference from predicate devices, but they all met the requirements of the same standard, and subject device is based on the up to date version of standards (in the standard ASTM F2100, the test method for "Differential Pressure" refer to EN 14683 instead of MIL-M-36954C). So, the differences between the subject device and predicate devices will not affect the safety and effectiveness.

9. Summary of Non-Clinical Performance Testing

Non-clinical tests were conducted to verify that the proposed device met all design specifications as the predicate device. The subject device has been evaluated the safety and performance by lab bench testing as follows according to the requirements stated in the Guidance for Industry and FDA Staff: Surgical Masks - Premarket Notification [510(k)] Submission issued on March 5, 2004.

Performance Testing summary:

Item	Proposed device	Acceptance Criteriafor Level 1	Test Results
Fluid ResistancePerformance (mmHg)ASTM F1862	Passed at 80mm Hg	29 out of 32 pass at 80mmHg	Passed at 80mmHg
Particulate FiltrationEfficiency Performance (%)ASTM F2299	Passed at 99.3%	≥ 95%	Passed at 99.3%
Bacterial Filtration EfficiencyPerformance (%)ASTM F2101	Passed at 98.1%	≥ 95%	Passed at 98.1%
Differential Pressure (Delta-P) (mm H2O/cm²)MIL-M-36954C	Passed at 4.8mmH2O/cm²	<5.0 mm H2O/cm²	Passed at 4.8mmH2O/cm²
Flammability classClass 116 CFR 1610	Class 1	Class 1	Class 1

Biocompatibility Testing Summary:

According to ISO 10993-1: 2018, the nature of body contact for the subject device is the Surface Device category, Skin Contact, and duration of the contact is B- prolonged (>24 h to 30 d). The following tests for the subject device were conducted to demonstrate that the subject device is biocompatible and safe for its intended use:

Test Item	Proposed device	Result
Cytotoxicity	Under the conditions of the study, the subject device extract was determined tobe non-cytotoxic.	PASS

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Irritation	Under the conditions of the study, the subject device non-polar and polar extractswere determined to be non-irritating.	PASS
Sensitization	Under the conditions of the study, the subject device non-polar and polar extractswere determined to be non-sensitizing.	PASS

10. Summary of Clinical Performance Test

No clinical study is included in this submission.

11. Comparison to predicate device and conclusion

The conclusion drawn from the nonclinical tests demonstrates that the subject device in 510(K) submission K202316, the Medical mask is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K153409.

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.