The Single-Use 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 Single-Use Surgical Mask 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.

Model: M and L, blue color, and Level 3 barrier level as ASTM F2100

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 meet Level 3 requirements per ASTM F2100.

The proposed device(s) are manufactured with three layers, the inner and outer layers are made of PP spun-bond non-woven fabric, and the middle layer is made of Melt-blown non-woven fabric. The blue colorant is blue masterbatch.

The Single-Use 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 not made with Polypropylene fiber.

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 malleable aluminum wire.

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

There are two models included, Model M and L. The two models share the same indication for use, instruction for use, material used, and structure. The dimension, the model L is bigger than model M.

AI/ML Overview

The provided document is a 510(k) premarket notification for a Single-Use Surgical Mask, not an AI/ML medical device. Therefore, many of the requested criteria regarding AI/ML model acceptance (e.g., sample size for test/training sets, data provenance, expert ground truth, MRMC studies, standalone performance) are not applicable.

The document focuses on demonstrating substantial equivalence to a predicate device primarily through non-clinical performance testing and biocompatibility testing, along with a comparison of physical characteristics.

Here's the relevant information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Name of the Test Methodology/Standard	Purpose	Acceptance Criteria (FDA/ASTM F2100 Level 3 Requirements)	Reported Device Performance (Proposed Device K201924)
ASTM F1862 (Fluid Resistance)	Resistance to penetration by synthetic blood	160 mm Hg	160 mm Hg
ASTM F2299 (Particulate Filtration Efficiency)	Sub-micron particulate filtration efficiency at 0.1 micron	≥ 98%	≥ 99.03%
ASTM F2101 (Bacterial Filtration Efficiency)	Bacterial Filtration Efficiency	≥ 98%	≥ 99.50%
MIL-M-36954C (Differential Pressure)	Differential Pressure	< 6.0 mm H₂O/cm²	≤ 5.1 mm H₂O/cm²
16 CFR 1610 (Flammability)	Flammability	Class 1	Class 1
ISO 10993-5 (Cytotoxicity)	Cytotoxicity	No cytotoxicity effect	Under the conditions of the study, no cytotoxicity effect
ISO 10993-10 (Irritation)	Irritation	No irritation effect	Under the conditions of the study, no irritation effect
ISO 10993-10 (Sensitization)	Sensitization	No sensitization effect	Under conditions of the study, no sensitization effect

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

The document does not specify the sample sizes (number of masks tested) for each non-clinical test.
Data Provenance: The tests were conducted by the manufacturer, Qiqihar Hengxin Medical Supplies, Ltd., in China. The data itself is "non-clinical testing" as opposed to "patient data".

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):

Not applicable. This pertains to AI/ML ground truth establishment. For surgical masks, "ground truth" is established by adherence to specified performance standards (e.g., ASTM F2100, 16 CFR 1610, ISO 10993). The performance is measured directly by laboratory tests, not by expert consensus on interpretations.

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

Not applicable. This pertains to AI/ML ground truth establishment for image or signal interpretation. Performance of a surgical mask is determined by standardized physical/biological tests, not by human adjudication of data interpretations.

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/ML device, so no MRMC study was performed. The study is a non-clinical performance comparison to a predicate device.

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

No. This is not an AI/ML device. The "standalone performance" here refers to the performance of the device itself (the mask) in physical and biological tests.

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

The "ground truth" for this device is based on pre-defined, internationally recognized performance standards and methodologies (e.g., ASTM F1862, ASTM F2299, ASTM F2101, MIL-M-36954C, 16 CFR 1610, ISO 10993) which specify how physical and biological properties are measured and what constitutes acceptable performance for a Level 3 surgical mask.

8. The sample size for the training set:

Not applicable. This is not an AI/ML device, so there is no "training set."

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

Not applicable. This is not an AI/ML device.

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 15, 2021

Qiqihar Hengxin Medical Supplies, 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: K201924

Trade/Device Name: Single-Use Surgical Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: February 23, 2021 Received: February 26, 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 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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Indications for Use

510(k) Number (if known) K201924

Device Name Single-Use Surgical Mask

Indications for Use (Describe)

Model: M and L, blue color, and Level 3 barrier level as ASTM F2100

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

☐ Prescription Use (Part 21 CFR 801 Subpart D)	☑ Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary

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.

The 510(k) Number: K201924

1. Date of Preparation:2021/03/13
1. Sponsor Identification

Oigihar Hengxin Medical Supplies, Ltd.

10th Beijiang Road in Tiefeng Industrial Park, North Shuguang Ave. Tiefeng District, Qiqihar, Heilongjiang Province, China, 161000

Contact Person: Sihui Xiong Position: Commercial Manager Tel: +86-452-5656959 Email: 476923513@qq.com

1. Designated Submission Correspondent
  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

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4. Identification of Proposed Device

Trade Name: Single-Use Surgical Mask Common Name: Surgical Face Mask Model(s): M, L

Regulatory Information Classification Name: Surgical Face Mask Classification: II Product Code: FXX Regulation Number: 878.4040 Review Panel: Surgical Apparel

Indication for use Statement:

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 meet Level 3 requirements per ASTM F2100.

The Single-Use 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 not made with Polypropylene fiber.

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 malleable aluminum wire.

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

There are two models included, Model M and L. The two models share the same indication for use, instruction for use, material used, and structure. The dimension, the model L is bigger than model M.

5. Identification of Predicate Device(s)

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Predicate Device K191355 3M High Fluid-Resistant Procedure Mask 3M Health Care

Summary of Non-Clinical Testing 6.
The following performance data has been provided to demonstrate that the subject device meet the acceptance criteria in the standard.

Name of the TestMethodology/standard	Purpose	Acceptance Criteria	Results
ASTM F1862	Resistance to penetrationby synthetic blood	160 mm Hg	160 mm Hg
ASTM F2299	Sub-micron particulatefiltration efficiency at 0.1micron	$\geq 98%$	$\geq99.03%$
ASTM F2101	Bacterial FiltrationEfficiency	$\geq 98%$	$\geq99.50%$
MIL-M-36954C	Differential Pressure	$< 6.0 mm H_2O/cm^2$	$\leq 5.1 mm H_2O/cm^2$
16 CFR 1610	Flammability	Class 1	Class 1
ISO 10993-5	Irritation	No irritation effect	Under the conditionsof the study, noirritation effect
	Sensitization	No sensitizationeffect	Under conditions ofthe study, nosensitization effect
ISO 10993-10	Cytotoxicity	No cytotoxicity effect	Under the conditionsof the study, nocytotoxicity effect

1. Clinical Test Conclusion
  No clinical study is included in this submission.

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Substantially Equivalent (SE) Comparison 8.

ITEM	Proposed Device K201924	Predicate Device K191355	Remark
Intended Use	The Single-Use 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 Single-Use Surgical Mask 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.Model: M and L, blue color, and Level 3 barrier level as ASTM F2100.	The 3M High Fluid-Resistant Procedure 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 potential exposure to blood and body fluids. The face mask is single use, disposable device, provide non-sterile.	SAME
Basic Design	Ear Loops, Flat Pleated, 3 layers	Ear Loops, Tie-On, Flat Pleated, 4 layers	Different
Materials	Outer Facing Layer	Spun-bond non-woven fabric	Polypropylene Spunbond	Similar
	Insertion	Not Applicable	Polypropylene Spunbond
	Middle Layer	Melt blown non-woven fabric	Polypropylene Melt blown
	Inner Facing Layer	Spun-bond non-woven fabric	Polypropylene Thermal-bonded
	Nose Piece	Malleable aluminum wire	Polyethylene Coated Steel
	Ear Loops	Polyester	Spandex elastic cord (Polyurethane core with polyethylene terephthalate/nylon cover)
Color	Blue	Green	Different
Dimension (Length)	Model M: 14 cm ±1cmModel L: 18 cm ±1cm	6.9"±0.2" (17.5 cm±0.5cm)	Different
Dimension (Width)	9 cm +/- 1cm	3.5"±0.3" (8.9 cm±0.8cm)
OTC use	Yes	Yes	SAME
Single Use	Yes	Yes	SAME
Sterile	No	No	SAME
ASTM F2100 Level	Level 3	Level 3	SAME

Table 1 General Comparison

Table 2 Performance Characteristic Comparison

ITEM	ProposedDeviceK201924	PredicateDeviceK191355	ASTM F2100Requirements forLevel 3 Classification	Remark
Fluid ResistancePerformance ASTMF1862	160 mmHg	160 mmHg	160 mmHg	SAME
Particulate Filtration	$\ge$ 99.03%	$\ge$ 98%	$\ge$ 98%

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EfficiencyASTMF2299
Bacterial FiltrationEfficiency ASTMF2101	≥99.50%	≥98%	≥ 98%
Differential Pressure(Delta P) MIL-M-36954C	≤ 5.1 mmH2O/cm²	< 5.0 mmH2O/cm²	< 6.0 mmH2O/cm²
Flammability16 CFR 1610	Class 1	Class 1	Class 1	SAME

Table 3 Biocompatibility Comparison

ITEM	Proposed Device K201924	Predicate Device K191355	Remark
Cytotoxicity	Under the conditions of the study, notcytotoxicity effect as ISO 10993-5	Non-cytotoxic, Non-sensitizing, Non-irritating	SAME
Irritation	Under the conditions of the study, not anirritant as ISO 10993-10		SAME
Sensitization	Under conditions of the study, not asensitizer as ISO 10993-10		SAME

Difference Analysis

The Single-Use Surgical Mask has the different with the predicate device (3M High Fluid-Resistant Procedure Mask) in Basic Design, Materials, Color and Dimension. But those differences are not critical to the intended use of the device and are not expected to affect the safety and effectiveness of the device when used as labeled based on the nonclinical tests performed.

9. Conclusion

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