The Disposable medical surgical mask is intended to be worn to protect and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. The surgical mask 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 non-sterile.

Device Description

The Disposable medical surgical mask is intended to be worn to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. The surgical mask 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 non-sterile.

The proposed device(s) are Blue color, and Flat Pleated type mask, utilizing Ear Loops' way for wearing, and they all have Nose Piece design for fitting the facemask around the nose.

The proposed device(s) are manufactured with three layers, the inner and outer layers are made of polypropylene spunbond fabric, and the middle layer is made of polypropylene meltblown fabric.

The Disposable medical surgical mask is held in place over the user's mouth and nose by two elastic ear loops welded to the facemask. The elastic ear loops are made with nylon and spandex.

The nose piece contained in the proposed device(s) is in the layers of the facemask to allow the user to fit the facemask around their nose, which is made of polypropylene coated steel wire.

The proposed device(s) are sold non-sterile and are intended to be single-use, disposable devices.

AI/ML Overview

The acceptance criteria and device performance for the "Disposable medical surgical mask" (K212097) are detailed in the provided tables.

1. Table of Acceptance Criteria and Reported Device Performance

Test Method	Purpose	Acceptance Criteria	Reported Device Performance (K212097)
ASTM F1862	Resistance to penetration by synthetic blood	160 mm Hg	160 mm Hg (32 out of 32 pass)
ASTM F2299	Sub-micron particulate filtration efficiency at 0.1 micron	≥ 98%	≥ 99%
ASTM F2101	Bacterial Filtration Efficiency	≥ 98%	≥ 99%
EN 14683 Annex C	Differential Pressure	< 6.0 mm H2O/cm²	< 4.9 mm H2O/cm²
16 CFR 1610	Flammability	Class 1	Class 1
ISO 10993-10	Irritation	No irritation effect	No irritation effect
ISO 10993-10	Sensitization	No sensitization effect	No sensitization effect
ISO 10993-5	Cytotoxicity	No cytotoxicity effect	No cytotoxicity effect

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

ASTM F1862 (Resistance to penetration by synthetic blood): The test involved 32 samples, "32 out of 32 pass at 160 mmHg."
For other tests (Particulate Filtration Efficiency, Bacterial Filtration Efficiency, Differential Pressure, Flammability, Biocompatibility), specific sample sizes are not explicitly stated in the provided document beyond the quantitative results.
Data Provenance: The document does not specify the country of origin of the data or whether the tests were retrospective or prospective. These are non-clinical (laboratory) tests performed on the device itself.

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

This submission concerns a medical mask, and the evaluation is based on non-clinical performance and biocompatibility testing against established ASTM, ISO, EN, and CFR standards. Therefore, clinical expert ground truth is not applicable in the context of this device's submission and approval process. The "ground truth" is defined by the requirements of the standards themselves.

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

Not applicable. This is not a clinical study involving human readers or cases requiring adjudication. The device performance is assessed through standardized laboratory tests.

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:

Not applicable. This device is a disposable medical surgical mask, not an AI-powered diagnostic or assistive tool.

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

Not applicable. This device is a physical product (mask), not an algorithm. The performance is inherent to the material and design of the mask as tested in laboratory settings.

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

The "ground truth" for the performance evaluation of the mask is based on established national and international standards for medical face masks and biological evaluation of medical devices. These standards (e.g., ASTM F2100, ASTM F1862, ASTM F2299, ASTM F2101, EN 14683, ISO 10993) define the methodologies and acceptance criteria for specific physical, mechanical, and biological properties.

8. The sample size for the training set:

Not applicable. This is a physical medical device (mask), not a machine learning model. There is no concept of a "training set" for its evaluation.

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

Not applicable, as there is no training set for this type of device. The performance is measured directly against predefined standard criteria.

Summary

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August 18, 2021

Hebei Titans Hongsen Medical Technology Co., LTD % Ray Wang General Manager Beijing Believe-Med Technology Service Co., Ltd Rm. 912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District Beijing, Beijing 102401 China

Re: K212097

Trade/Device Name: Disposable medical surgical mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: June 30, 2021 Received: July 6, 2021

Dear Ray 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.

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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); 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.

For Clarence W. Murray III, Ph.D. 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) K212097

Device Name Disposable medical surgical 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 - K212097

This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.

1. Date of Preparation:2021/08/18
1. Sponsor Identification

Hebei Titans Hongsen Medical Technology Co., Ltd

East Industrial Concentration Zone, Nangong City, Xingtai City, 055750, Hebei Province, China.

Contact Person: Chai Wu Position: Production Manager Tel: +86-17769045117 Fax: +86-0319-7295811 Email: 846920354@qq.com

Designated Submission Correspondent 3.
Mr. Ray Wang Beijing Believe-Med Technology Service Co., Ltd. Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District, Beijing, 102401, China Tel: +86-18910677558 Fax: +86-10-56335780 Email: Ray.Wang(@believe-med.com
1. Identification of Proposed Device
  Trade Name: Disposable medical surgical mask Common Name: Mask, Surgical

Regulatory Information Classification Name: Mask, Surgical Classification: II Product Code: FXX Regulation Number: 878.4040 Review Panel: General Hospital

Indication for use Statement:

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Device Description:

The proposed device(s) are Blue color, and Flat Pleated type mask, utilizing Ear Loops' way for wearing, and they all have Nose Piece design for fitting the facemask around the nose.

The proposed device(s) are manufactured with three layers, the inner and outer layers are made of polypropylene spunbond fabric, and the middle layer is made of polypropylene meltblown fabric.

The Disposable medical surgical mask is held in place over the user's mouth and nose by two elastic ear loops welded to the facemask. The elastic ear loops are made with nylon and spandex.

The nose piece contained in the proposed device(s) is in the layers of the facemask to allow the user to fit the facemask around their nose, which is made of polypropylene coated steel wire.

The proposed device(s) are sold non-sterile and are intended to be single-use, disposable devices.

ડ. Identification of Predicate Device(s)
510(k) number: K202511 Device Name: Disposable Medical Surgical Mask Manufacturer: Improve Medical (HuNan) Co., Ltd.

Technological Characteristics Comparison 6.

Table 1 General Comparison

ITEM	Proposed Device K212097	Predicate Device K202511	Remark
	ASTM F2100 Level 3	ASTM F2100 Level 3

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Indication for use		The Disposable medical surgical mask isintended to be worn to protect both the patientand healthcare personnel from the transfer ofmicroorganisms, body fluids, and particulatematerial. The surgical mask is intended for usein infection control practices to reduce thepotential exposure to blood and body fluids.This is a single-use, disposable device(s),provided non-sterile.	The Disposable Medical Surgical Masks areintended to be worn to protect both thepatient and healthcare personnel fromtransfer of microorganisms, body fluids andparticulate material. These face masks areintended for use in infection controlpractices to reduce the potential exposure toblood and body fluids. This is a single use,disposable device(s), provided non-sterile.	SAME
Basic Design		Ear Loops, Flat Pleated, 3 layers	Ear loops, Flat Pleated, 3 layers	SAME
Materials	Outer Facing Layer	polypropylene spunbond fabric	Spun-bond polypropylene	Analysis
	Middle Layer	polypropylene meltblown fabric	Melt-blown polypropylene filter
	Inner Facing Layer	polypropylene spunbond fabric	Spun-bond polypropylene
	Nose Piece	polypropylene coated steel wire	Polyethylene coated steel wire
	Ear Loops	nylon , spandex	Polyester
Color		Blue	Blue	SAME
Dimension		$17.5 \pm 5% \text{ cm}$	$17.5 \text{cm} \pm 0.2 \text{cm}$	Similar
	(Length, Width)	$9.5 \pm 5% \text{cm}$	$9.5 \pm 0.2 \text{cm}$
OTC use		Yes	Yes	SAME
Single Use		Single use, disposable	Single use, disposable	SAME
Sterile		Non-sterile	Non-sterile	SAME

Table 2 Performance Characteristic Comparison

ITEM	Proposed DeviceK212097	Predicate DeviceK202511	ASTM F2100Requirements	Remark
ASTM F2100 Level	Level 3	Level 3	Level 3	SAME
Fluid ResistancePerformance ASTMF1862	32 out of 32 pass at160 mmHg	32 out of 32 pass at 160 mmHg	160 mmHg	SAME
Particulate FiltrationEfficiency ASTMF2299	≥99%	Pass at 98.6%	≥ 98%
Bacterial FiltrationEfficiency ASTMF2101	≥99%	Pass at 99.9%	≥ 98%
DifferentialPressure (Delta P)EN 14683:2019+AC:2019 Annex C	< 4.9 mmH2O/cm2	Pass at 3.5 mmH2O/cm2	< 6.0 mmH2O/cm2
Flammability16 CFR 1610	Class 1	Class 1	Class 1	SAME

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ITEM	Proposed Device K212097	Predicate Device K202511	Remark
Cytotoxicity	Non-cytotoxic	Non-cytotoxic	SAME
Irritation	Non-irritating	Non-irritating	SAME
Sensitization	Non-sensitizing	Non-sensitizing	SAME

Table 3 Biocompatibility Comparison

Analysis:

The Disposable medical surgical mask is substantially equivalent to the Improve Medical (HuNan) Products Disposable Medical Surgical Mask. Based on the nonclinical tests performed, the subject device is as safe, as effective, and performs as well as the legally marketed predicate device, Disposable Medical Surgical Mask cleared under K202511.

1. Non-Clinical Test Conclusion
  The test results demonstrated that the proposed device complies with the following standards:
A 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 F2100-19, Standard Specification For Performance Of Materials Used In Medical Face Masks.
ASTM F1862-17, Standard Test Method For Resistance Of Medical Face Masks To > Penetration By Synthetic Blood (Horizontal Projection Of Fixed Volume At A Known Velocity)
EN 14683-2019+AC:2019 Annex C, Medical face masks - Requirements and test methods;
ASTM F2101-19, Standard Test Method For Evaluating The Bacterial Filtration Efficiency (Bfe) Of Medical Face Mask Materials, Using A Biological Aerosol Of Staphylococcus Aureus;
ASTM F2299-03, 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;

Test Method	Purpose	Acceptance Criteria	Results
ASTM F1862	Resistance to penetrationby synthetic blood	160 mm Hg	160 mm Hg

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ASTM F2299	Sub-micron particulatefiltration efficiency at 0.1micron	$\geq 98%$	$\geq 99%$
ASTM F2101	Bacterial FiltrationEfficiency	$\geq 98%$	$\geq 99%$
EN 14683Annex C	Differential Pressure	$< 6.0 mm H2O/cm²$	$< 4.9 mm H2O/cm²$
16 CFR 1610	Flammability	Class 1	Class 1
ISO 10993-10	Irritation	No irritation effect	Under the conditions ofthe study, noirritation effect
	Sensitization	No sensitizationeffect	Under conditions ofthe study, nosensitization effect
ISO 10993-5	Cytotoxicity	No cytotoxicity effect	Under the conditionsof the study, nocytotoxicity effect

8. Clinical Test Conclusion

No clinical study is included in this submission.

9. Conclusion

The conclusions drawn from the nonclinical tests demonstrate that the device is as safe, as effective, and performs as well as or better the legally marketed device.

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.