The Disposable Medical Face 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 reduce the potential exposure to blood and body fluids. The Disposable Medical Face Masks are single use, disposable device, provided non-sterile.

Device Description

Disposable Medical Face Mask is composed of three layers and is flat-pleated. The mask materials consist of an outer layer (spun-bond polypropylene), a middle layer, between the outer layer and inner layers (melt-blown polypropylene), and an inner layer (Spun-bond polypropylene). Each mask contains ear loops to secure the mask over the users' mouth and face and includes a malleable nose piece (galvanized iron wire) to provide a firm fit over the nose.

AI/ML Overview

Here's a breakdown of the requested information based on the provided FDA 510(k) summary for the Disposable Medical Face Mask:

1. Table of Acceptance Criteria and Reported Device Performance

Performance Characteristic	Acceptance Criteria (for Level 2)	Reported Device Performance
Bacterial Filtration Efficiency (BFE) (ASTM F2101)	≥98%	Pass (≥98%)
Differential Pressure (Delta-P) (EN 14683)	<6.0 mmH₂O/cm²	Pass (<6.0 mmH₂O/cm²)
Sub-Micron Particulate Filtration Efficiency (PFE) at 0.1 micron (ASTM F2299)	≥98%	Pass (≥98%)
Resistance to Penetration by Synthetic Blood (ASTM F1862)	Fluid resistant at 120 mmHg	Pass
Flammability (16 CFR Part 1610)	Class 1 Non-Flammable	Class 1 Non-Flammable
Cytotoxicity (ISO 10993-5)	Non-cytotoxic	Non-cytotoxic
Irritation (ISO 10993-10)	Non-irritating	Non-irritating
Sensitization (ISO 10993-10)	Non-sensitizing	Non-sensitizing

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample size for each performance test. It mentions for Fluid Resistance (ASTM F1862) that "32 out of 32 Pass at 120mmHg". This implies a sample size of 32 for that specific test. For other performance tests (BFE, Delta-P, PFE, Flammability) and biocompatibility tests, the sample sizes are not explicitly provided within this summary.

The data provenance is not specified (e.g., country of origin, retrospective/prospective). The submitting company is Suzhou Bolisi Medical Technology Co., Ltd in China, which suggests the testing was likely conducted in China or a contracted lab. It's safe to assume these are prospective tests performed specifically for this submission.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not applicable to this type of device. The ground truth for performance standards of medical masks is established by standardized test methods (e.g., ASTM, EN, ISO) and the results are objectively measured by laboratories, not through expert consensus on cases.

For biocompatibility testing, the results are also determined by standardized laboratory assays, not by expert review of "cases."

4. Adjudication Method for the Test Set

This is not applicable as the tests performed are objective, quantitative measurements against predefined criteria, not subjective assessments requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically used for diagnostic or imaging devices where human interpretation is involved. For a product like a disposable medical face mask, the assessment relies on objective performance testing and biocompatibility.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, this is not applicable. This device is not an algorithm or AI system. It is a physical medical device.

7. The Type of Ground Truth Used

The "ground truth" for this device is based on established performance standards and test methodologies for medical face masks and biocompatibility. Specifically:

Performance Standards: ASTM F2101, EN 14683, ASTM F2299, ASTM F1862, 16 CFR Part 1610. These standards define the acceptable physical and filtration properties.
Biocompatibility Standards: ISO 10993-5 (cytotoxicity), ISO 10993-10 (irritation and sensitization). These standards define the acceptable biological response to the device materials.

8. The Sample Size for the Training Set

This is not applicable. There is no "training set" for this type of medical device. The device's performance is not based on a machine learning model that needs training data.

9. How the Ground Truth for the Training Set Was Established

This is not applicable for the same reason as above.

Summary

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July 12, 2021

Suzhou Bolisi Medical Technology Co., Ltd % Ryan Li RA Manager Shanghai Mind-link Business Consulting Co., Ltd. Room A08, Floor 14th, No 699, Jiaozhou Road, Jingan District Shanghai. 200040 China

Re: K210244

Trade/Device Name: Disposable Medical Face Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: June 7, 2021 Received: June 10, 2021

Dear Ryan Li:

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 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,

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 Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K210244

Device Name

Disposable Medical Face Mask(145mm95mm). Blue. Ear Loop type Disposable Medical Face Mask(175mm95mm), Blue, Ear Loop type

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-K210244

I. SUBMITTER:

Suzhou Bolisi Medical Technology Co.,Ltd Baijiaqiao industrial community, Yangshe Town, Zhangjiagang City, Jiangsu Province, China Contact Person: Hong Xu Title: General Manager Tel: +86 13776246881 Email: zjgbolisi@163.com

Submission Correspondent: Ryan Li Email: ryan.li@mind-link.net Tel:+86 13701581791

Summary prepared: June 28, 2021

II. DEVICE

Name of Device: Disposable Medical Face Mask Regulation Number: 21 CFR PART 878.4040 Common Name: Surgical Mask Classification Name: Surgical Mask Regulatory Class: II Product Code: FXX

III. PREDICATE DEVICE

Predicate: K210007

Trade/Device Name: Face Mask

Manufacturer: Jinhua Jingdi Medical Supplies Co.,Ltd

Product Code: FXX

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Classification Name: Mask, surgical

Regulation Number: 21 CFR 878.4040

IV. DEVICE DESCRIPTION

V. AVAILABLE MODELS

The Disposable Medical Face Masks are available in two models including different sizes.

For the 145mm95mm model is in blue, barrier level 2 and size 145mm95mm, ear loop type.

For the 175mm95mm model is in blue, barrier level 2 and size 175mm95mm, ear loop type.

VI. INDICATIONS FOR USE

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH VII. THE PREDICATE DEVICE

The Disposable Surgical Masks are compared with the predicate device (Face Mask (K210007)). The results are shown below in the Technological Characteristics Comparison Table:

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DEVICE	Subject Device	Primary Predicate Device	Comparison
	Disposable Medical Face Mask	Face Mask (K210007 )
Intended Use	The Disposable Medical Face 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 reduce the potential exposure to blood and body fluids. The Disposable Medical Face Masks are single use, disposable device, provided non-sterile.	The face mask 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 reduce the potential exposure to blood and body fluids. The face mask is a single-use, disposable device, provided non-sterile.	Same
Classification	FXX	FXX	Same
Product Code
Ear Loop Model	Ear Loops	Ear Loops	Same
Materials
Outer Layer	Facing Spun-bond polypropylene non-woven fabric	Spun-bond polypropylene non-woven fabric	Similar Note 1
Middle Layer	Melt-blown polypropylene	Melt-blown polypropylene	Similar Note 1
Inner Layer	Facing Spun-bond polypropylene non-woven fabric	Spun-bond polypropylene non-woven fabric	Similar Note 1
Nose Piece	Galvanized iron wire	Iron wire covered polypropylene	Different Note 1
Ear Loops	82% Spandex18% Polyester	75% Polyester25% Spandex	Similar Note 1
Design Features
Color	Blue	Blue	Same
Style	Flat - Pleated	Flat - Pleated	Same
Multiple Layers	3 Layers	3 Layers	Same
Single Use	Single use	Single use	Same
	Sterility
Sterile	Non-sterile	Non-sterile	Same
Dimensions
Length × Width	$145\times95$ mm (±5mm)$175\times95$ mm (±5mm)	$145\times95$ mm (±5mm)$175\times95$ mm (±5mm)	Same
Technological Characteristics Product Barrier Specifications Per ASTM F2100 – Meets Level 2
Fluid ResistanceASTM F1862	32 out of 32 Pass at 120mmHg	32 out of 32 pass at 120mmHg	Same
ParticulateFiltrationEfficiency (PFE)ASTM F2299	Pass at ≥98%	Pass at 99.70%	SimilarNote 2
BacterialFiltrationEfficiency (BFE)ASTM F2101	Pass at ≥98%	Pass at 99.95%	SimilarNote 2
DifferentialPressure (DeltaP)MIL-M-36954C	Pass at $<6.0$ mmH2O/cm²	Pass at 3.0 mmH2O/cm²	SimilarNote 2
Flammability16 CFR PART1610	Class 1 Non-Flammable	Class 1 Non-Flammable	Same
Biocompatibility
Cytotoxicity	Under the conditions of the study, the subject device extract was determined to be non-cytotoxic.		Same
Irritation	Under the conditions of the study, the subject device non-polar and polar extracts were determined to be non-irritating.		Same
Sensitization	Under the conditions of the study, the subject device non-polar and polar extracts were determined to be non-sensitizing.		Same

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Comparison in Detail(s): Note 1:

Although the material including outer layer, middle layer, inner layer, nose piece and ear loops is a little different from the predicate device, it meets the requirement of essential performance standard ISO 10993. The differences between the predicate device and subject device will not affect the safety and effectiveness of the subject device.

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Note 2:

Although the Particulate Filtration Efficiency, Bacterial Filtration Efficiency and Differential Pressure of the subject device is a little different from the predicate device. However, they all meet the requirements of essential performance standard ASTM F 2100. Therefore, the differences between the predicate device and subject device will not affect the safety and effectiveness of the subject device.

VIII. PERFORMANCE DATA

PerformanceCharacteristics	Test Method	Pass CriteriaFor Level 2	Test Results
BacterialFiltrationEfficiency	ASTM F2101 Standard Methodfor Evaluating the BacterialFiltration Efficiency (BFE) ofMedical Face Mask Materials,Using a Biological Aerosol ofStaphylococcus aureus	≥98%	Pass
DifferentialPressure(Delta-P)	EN 14683: 2019, Annex CMedical face masks -Requirements and test methodsaccording to ASTM F2100:2019	<6.0 mmH2O/cm²	Pass
Sub-MicronParticulateFiltrationEfficiency(PFE) at 0.1micron	ASTM F2299 Standard TestMethod for Determining theInitial Efficiency of MaterialsUsed in Medical Face Masks toPenetration by ParticulatesUsing Latex Spheres	≥98%	Pass
Resistance toPenetration bySyntheticBlood	ASTM F1862 Standard TestMethod for Resistance ofMedical Face Masks toPenetration by Synthetic Blood(Horizontal Projection of FixedVolume at a Known Velocity)	Fluid resistant at120 mm Hg	Pass
Flammability	16 CFR Part 1610 Standard forthe Flammability of Clothing	Class 1	Pass

Summary of Non-Clinical Performance Test

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Biocompatibility Testing

Based on ISO 10993-1:2018, the subject device contacts intact skin and its contact duration is less than or equal to 24h. Therefore, the following tests for the subject device were conducted to demonstrate that the subject device is biocompatible and safe for its intend use:

In vitro Cytotoxicity Test per ISO 10993-5: 2009 Biological evaluation of ● medical devices- Part 5: Tests for in vitro cytotoxicity
Skin Sensitization Tests per ISO 10993-10: 2010 Biological evaluation of ● medical devices- Part 10: Tests for irritation and skin sensitization
Skin Irritation Tests per ISO 10993-10: 2010 Biological evaluation of medical devices- Part 10: Tests for irritation and skin sensitization

Clinical Test

No clinical study is included in this submission.

IX. CONCLUSION

The conclusion drawn from the nonclinical tests demonstrates that the subject device, the Disposable Medical Face Mask is as safe, as effective, and performs as well as the legally marketed predicate device Face Mask (K210007).

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.