Surgical 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. Surgical Face Masks are single use, disposable devices, provided non-sterile.

Device Description

Surgical Face Mask contains one model called YOD2001. YOD2001 Surgical Face Mask is in white, barrier level 2, size 173mm*97mm, flat pleated and ear loop type. YQD2001 Surgical Face Mask is a flat pleated type mask composed of three layers. The mask materials consist of an outer layer (spun-bond polypropylene), a middle layer, between the outer 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 made of polypropylene to provide a firm fit over the nose.

AI/ML Overview

This document is a 510(k) Premarket Notification for a Surgical Face Mask. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study of an AI/ML algorithm's performance. Therefore, many of the requested criteria related to AI/ML device studies (such as sample size for test sets/training sets, expert ground truth, MRMC studies, standalone algorithm performance, and effect size) are not applicable or provided in this document.

However, I can extract information related to the performance testing of the physical surgical mask against established standards.

Acceptance Criteria and Device Performance (for the physical mask):

The acceptance criteria are derived from ASTM F2100 - Level 2 standards. The reported device performance indicates that the Surgical Face Mask met all these criteria.

Performance Characteristics	Test Method	Acceptance Criteria (Level 2)	Reported Device Performance
Bacterial Filtration Efficiency (BFE)	ASTM F2101 Standard Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus	≥98%	Pass
Differential Pressure (Delta-P)	EN 14683: 2019, Annex C Medical face masks - Requirements and test methods according to ASTM F2100:2019	<6.0 mm H2O/cm²	Pass
Sub-Micron Particulate Filtration Efficiency (PFE) at 0.1 micron	ASTM F2299 Standard Test Method for Determining the Initial Efficiency of Materials Used in Medical Face Masks to Penetration by Particulates Using Latex Spheres	≥98%	Pass
Resistance to Penetration by Synthetic Blood	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)	Fluid resistant claimed at 120 mm Hg	Pass
Flammability	16 CFR Part 1610 Standard for the Flammability of Clothing	Class 1	Pass
Biocompatibility: Cytotoxicity	ISO 10993-5: 2009 Biological evaluation of medical devices- Part 5: Tests for in vitro cytotoxicity	Non-cytotoxic	Non-cytotoxic
Biocompatibility: Irritation	ISO 10993-10: 2010 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization	Non-irritating	Non-irritating
Biocompatibility: Sensitization	ISO 10993-10: 2010 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization	Non-sensitizing	Non-sensitizing

Regarding AI/ML Specific Criteria (which are not applicable to this document):

Sample sized used for the test set and the data provenance: Not applicable. This document describes testing for a physical mask, not an AI/ML algorithm.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The "ground truth" for the mask is based on standardized physical and material tests, not expert interpretation of outputs.
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 not an AI-assisted device.
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 for this device is based on established laboratory testing standards (e.g., ASTM, EN, ISO) for physical properties, filtration efficiency, fluid resistance, flammability, and biocompatibility.
The sample size for the training set: Not applicable. This is not an AI/ML algorithm that requires a training set.
How the ground truth for the training set was established: Not applicable.

Summary of the study that proves the device meets the acceptance criteria (for the physical mask):

The device underwent non-clinical performance testing and biocompatibility testing.

Non-Clinical Performance Test: The mask was tested for Bacterial Filtration Efficiency (BFE), Differential Pressure (Delta-P), Sub-Micron Particulate Filtration Efficiency (PFE), Resistance to Penetration by Synthetic Blood, and Flammability. The specific test methods (ASTM F2101, EN 14683 Annex C, ASTM F2299, ASTM F1862, 16 CFR Part 1610) and acceptance criteria for Level 2 masks were applied. The device "Passed" all these tests.
Biocompatibility Testing: Based on ISO 10993-1:2018, tests for Cytotoxicity (ISO 10993-5), Skin Sensitization (ISO 10993-10), and Skin Irritation (ISO 10993-10) were conducted since the device contacts intact skin for less than or equal to 24 hours. The results for all these tests indicated "Non-cytotoxic," "Non-sensitizing," and "Non-irritating" respectively.

Data Provenance: The document does not explicitly state the country of origin for the test data, nor whether the tests were retrospective or prospective. However, tests following established international and US standards (ASTM, EN, ISO, CFR) are inherently prospective performance evaluations. No clinical study was included in this submission.

Summary

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December 6, 2021

Shanghai Yunqing Industrial 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: K212235

Trade/Device Name: Surgical Face Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: October 28, 2021 Received: November 8, 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.

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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, PhD 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 K212235

Device Name Surgical Face 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-K212235

I. SUBMITTER:

Shanghai Yunqing Industrial Co., Ltd. 2nd buliding1818, shangsu road,fengxian district, Shanghai, China Contact Person: Hulin Title: QA Manager Tel: +86 15921265138 Email: HL@yqgroup.vip

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

Summary prepared: October 26, 2021

II. DEVICE

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

III. PREDICATE DEVICE

Primary predicate device:

Predicate: K182514 Trade/Device Name: Surgical Face Mask Manufacturer: Xiantao Zhibo Non-Woven Products Co., Ltd Product Code: FXX Classification Name: Mask, surgical Regulation Number: 21 CFR 878.4040

IV. DEVICE DESCRIPTION

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Surgical Face Mask contains one model called YOD2001.

YOD2001 Surgical Face Mask is in white, barrier level 2, size 173mm*97mm, flat pleated and ear loop type.

YQD2001 Surgical Face Mask is a flat pleated type mask composed of three layers. The mask materials consist of an outer layer (spun-bond polypropylene), a middle layer, between the outer 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 made of polypropylene to provide a firm fit over the nose.

V. INDICATIONS FOR USE

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

Surgical Face Masks are compared with the predicate device Surgical Face Mask (K182514). The results are shown below in the Technological Characteristics Comparison Table:

DEVICE	Subject Device	Primary Predicate Device	Remark
	Surgical Face Mask	Surgical Face Mask (K182514)
Intended Use	The Surgical 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. Surgical Face Masks are single	The surgical 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. This is a single-use, disposable device, provided	Same
	use, disposable devices, providednon-sterile.
	non-sterile.
Classification	FXX	FXX	Same
Product Code
Model	Ear Loop	Ear loop	Same
	Materials
Outer Facing Layer	Spun-bondnon-woven fabric	polypropylene Spun-bond polypropylene	SimilarNote 1
Middle Layer	Polypropylenenon-woven fabric	melt-blown Melt blown polypropylene filter	SimilarNote 1
Inner Facing Layer	Spun-bondnon-woven fabric	polypropylene Spun-bond polypropylene	SimilarNote 1
Nose Clip	Iron wire coatedpolypropylene	with Malleable aluminum wire	SimilarNote 1
Ear Loop/Headband	20% Spandex 80% Polyester	Polyester	SimilarNote 1
	Design Features
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
	Dimension
Length Width	173mm X 97mm	175mm X 95mm	DifferentNote 2
Technological Characteristics Product Barrier Specifications Per ASTM F2100 – Meets Level 2
Fluid ResistanceASTM F1862	Pass at 120mmHg	Pass at 120mmHg	Similar
Particulate FiltrationEfficiency (PFE)ASTM F2299	Pass at >98%	Pass at >98%	Similar
Bacterial FiltrationEfficiency (BFE)ASTM F2101	Pass at >98%	Pass at >98%	Similar
Differential Pressure(Delta P)MIL-M-36954C	Pass at <6 mmH2O/cm²	Pass at <6 mmH2O/cm²	Similar
Flammability16 CFRPART 1610	Class 1 Non-Flammable	Class 1 Non-Flammable	Similar
Biocompatibility
Cytotoxicity	Under the conditions of the study, the subject device extract was determined to be non-cytotoxic.	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.	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.	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 facing layer, middle layer, inner facing layer, nose piece, ear loops is different from the predicate device, the subject device meet 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.

Note 2

There is a slightly difference of the mask dimensions between the subject device and the predicate device. However, both the subject and predicate device meet the ASTM F2100-19 barrier protection level 2. Therefore, the differences between the predicate device and subject device will not affect the safety and effectiveness of the subject device.

VII. PERFORMANCE DATA

Summary of Non-Clinical Performance Test

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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 resistantclaimed at 120mm Hg	Pass
Flammability	16 CFR Part 1610 Standard forthe Flammability of Clothing	Class 1	Pass

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

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Clinical Test Conclusion

No clinical study is included in this submission.

VIII. CONCLUSION

The conclusion drawn from the nonclinical tests demonstrates that the subject device, Surgical Face Masks are as safe, as effective, and performs as well as or better than the legally marketed predicate device Surgical Face Mask (K182514).

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.