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 a single use, disposable device(s), provided non-sterile.

Device Description

The Surgical Face Masks are blue, flat pleated masks with ear loops to hold the device in place over the user's mouth and nose and a nose piece to fit the mask to the face. The proposed device(s) are manufactured with three layers, the inner and outer layers are made of spun-bond polypropylene, and the middle layer is made of melt blown polypropylene filter. The ear loops are polyester. They are not made with natural rubber latex. The nose piece contained in the proposed device(s) is in the layers of face mask and is made of malleable aluminum wire. The proposed device(s) are sold non-sterile and are intended to be single use, disposable device.

AI/ML Overview

The provided text is a 510(k) Summary for a Surgical Face Mask. This type of document is for demonstrating substantial equivalence to a predicate device, primarily through non-clinical testing and comparison of technical specifications, rather than clinical studies proving a specific performance metric against a disease outcome or a human-AI comparative effectiveness study for an AI-based medical device.

Therefore, many of the requested points related to AI/MRMC studies, ground truth establishment, expert consensus, and human reader performance are not applicable to this submission. This document focuses on the physical and performance characteristics of a surgical face mask.

Here's an analysis based on the provided document:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for this medical device (surgical face mask) are based on established international and national standards for material performance and safety, primarily
ASTM F2100 for medical face mask performance, and ISO 10993 for biocompatibility.

Table of Acceptance Criteria and Reported Device Performance:

Test Method	Purpose	Acceptance Criteria	Reported Device Performance
Biocompatibility Testing (ISO 10993)
Cytotoxicity	To demonstrate the biocompatibility of the subject device.	Non-Cytotoxic	PASS: Under the conditions of the study, the device is non-cytotoxic.
Irritation	To demonstrate the biocompatibility of the subject device.	Non-Irritating	PASS: Under the conditions of the study, the device is non-irritating.
Sensitization	To demonstrate the biocompatibility of the subject device.	Non-Sensitizing	PASS: Under the conditions of the study, the device is non-sensitizing.
Performance Testing (ASTM F2100, etc.)
Fluid Resistance ASTM F1862	To demonstrate the functionality of the subject device.	For Level 2: 29 out of 32 pass at 120 mmHg. For Level 3: 29 out of 32 pass at 160 mmHg.	PASS: 32 out of 32 per lot pass at 120 mmHg (3 non-consecutive lots tested).32 out of 32 per lot pass at 160 mmHg (2 non-consecutive lots tested).30 out of 32 per lot pass at 160 mmHg (1 lot tested).(This indicates the device meets both Level 2 and Level 3 fluid resistance requirements, although it's categorized as Level 2 & 3 in the summary and compared to a Level 2 predicate).
Particulate Filtration Efficiency ASTM F2299	To demonstrate the functionality of the subject device.	≥ 98%	PASS: 3 non-consecutive lots tested, using a sample size of 32/lot. Lot1: 99.79%Lot2: 99.58%Lot3: 99.6%
Bacterial Filtration Efficiency ASTM F2101	To demonstrate the functionality of the subject device.	≥ 98%	PASS: 3 non-consecutive lots tested, using a sample size of 32/lot. Lot1: 99.56%Lot2: 99.9%Lot3: 99.84%
Differential Pressure (Delta P) EN 14683 Annex C	To demonstrate the functionality of the subject device.	< 6.0 mmH2O/cm²	PASS: 3 non-consecutive lots tested, using a sample size of 32/lot. Lot1: 5.2 mmH2O/cm²Lot2: 3.8 mmH2O/cm²Lot3: 3.8 mmH2O/cm²
Flammability 16 CFR 1610	To demonstrate the functionality of the subject device.	Class 1	PASS: 3 non-consecutive lots tested, using a sample size of 32/lot. Class 1.

Study Details:

Sample sizes used for the test set and the data provenance:
- For biocompatibility tests (Cytotoxicity, Irritation, Sensitization), specific sample sizes are not explicitly stated as numerical values (e.g., number of masks or subjects), but the results indicate that the tests were performed sufficiently to declare "PASS" for the acceptance criteria.
- For performance tests (Fluid Resistance, Particulate Filtration, Bacterial Filtration, Differential Pressure, Flammability), the sample size for each lot tested was 32 units.
- Data Provenance: The tests were non-clinical, laboratory-based tests performed by the manufacturer, Macheng Thimble Technology Investment Co., Ltd, based in Hubei Province, China. The document does not specify whether the data is retrospective or prospective, as these terms typically apply to clinical studies using patient data. These are results from product testing.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable. The "ground truth" for this type of device is established by the specified performance standards (e.g., ASTM, ISO, EN). There is no "truth" established by human experts in the context of interpreting medical images or making diagnoses. The tests performed are objective, quantitative measurements.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods are relevant for studies involving human interpretation and consensus (e.g., in clinical trials or image reading studies). This submission relies on objective laboratory test results.
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 a physical product (surgical face mask), not an AI-based diagnostic or imaging device. Therefore, MRMC studies are irrelevant.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical product, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" or standard for compliance is defined by the acceptance criteria specified in recognized industry standards (ASTM F1862, ASTM F2299, ASTM F2101, EN 14683 Annex C, 16 CFR 1610, ISO 10993-5, ISO 10993-10). These are objective, measurable parameters.
The sample size for the training set:
- Not applicable. This is not an AI/machine learning device that requires a training set. The device is a manufactured product tested against established standards.
How the ground truth for the training set was established:
- Not applicable, as there is no training set for this type of device.

Summary

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Image /page/0/Picture/0 description: The image contains 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.

August 18, 2021

Macheng Thimble Technology Investment Co., Ltd % Ivy Wang Consultant Shanghai Sungo Management Consulting Company Limited 13th Floor, 1500# Central Avenue Shanghai 200122 China

Re: K211631

Trade/Device Name: Surgical Face Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical apparel Regulatory Class: Class II Product Code: FXX Dated: May 27, 2021 Received: May 27, 2021

Dear Ivy 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.

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 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 Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K211631

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

510(k) Number : K211631 Date Prepared:2021/8/18

A. Applicant:

Manufacturer: Macheng thimble Technology Investment Co., Ltd Address: No. 7 Xiling 2nd Rd, Macheng Economic Development Zone, Hubei Province Owner number: 3016965655 Contact Person: Donghong SHENG Address: No. 7 Xiling 2nd Rd, Macheng Economic Development Zone, Hubei Province Tel: +8613910635968 Mail: 470357243@qq.com

Submission Correspondent: Primary contact: Ms. Ivy Wang Shanghai SUNGO Management Consulting Co., Ltd. Room 1401 Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-58817802 Email: haiyu.wang@sungoglobal.com Secondary contact: Mr. Raymond Luo Room 1401, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-68828050 Email: fda.sungo@gmail.com

B. Device:

Proprietary Name: Surgical Face Mask Common Name: Surgical Face Mask Model(s): Ear loops

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

C. Predicate device:

510(k) Number: K203426 Sponsor: Nantong Taiweishi Medical Technology Co., Ltd. Trade Name: Surgical Face Mask (non-sterile ) (Note: Predicate device has NOT been subject to any Medical Device Recalls, including design-related recall.)

D. Device Description:

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with natural rubber latex. The nose piece contained in the proposed device(s) is in the layers of face mask and is made of malleable aluminum wire. The proposed device(s) are sold non-sterile and are intended to be single use, disposable device.

E. Indications use of the device:

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 intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This a single use, disposable device(s), provided non-sterile.

F. Comparison with predicate device

Table 1 General Comparison

Device	Proposed Device	Predicate device	Comparison
Manufacturer	MACHENG THIMBLETECHNOLOGY INVESTMENT CO.,LTD	Nantong Taiweishi MedicalTechnology Co., Ltd.	-
510K number	K211631	K203426	-
Device name	Surgical Face Mask	Surgical Face Mask (non-sterile )	-
Classification	Class II Device, FXX (21CFR878.4040)	Class II Device, FXX (21 CFR878.4040)	Same
Indications for use	The Surgical Face Masks are intendedto be worn to protect both the patientand healthcare personnel from transferof microorganisms, body fluids andparticulate material. These face masksare intended for use in infectioncontrol practices to reduce thepotential exposure to blood and bodyfluids. This a single use, disposabledevice(s), provided non-sterile.	The Disposable Surgical Face 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), providednon-sterile.	Same
Material	Outer layer	Spun-bond polypropylene	Spun-bond polypropylene	Same
	Middle layer	Melt blown polypropylene filter	Melt blown polypropylene filter	Same
	Inner layer	Spun-bond polypropylene	Spun-bond polypropylene	Same
	Nose clip	Malleable aluminum wire	Polyethylene	Different
	Ear loops	Polyester	Nylon and Spandex	Different
Color	Blue	Blue	Same
	Dimension(length)	$17.5cm+/-0.5cm$	$175mm+/-5%$	Similar
	Dimension(Width)	$9.5cm+/-0.5cm$	$95mm+/-5%$	Similar
	OTC use	Yes	Yes	Same
Sterility	Non-Sterile	Non-Sterile	Same
Use	Single Use, Disposable	Single Use, Disposable	Same
ASTM F2100 level	Level 2&3	Level 2	Similar
Biocompatibility	Meet ISO10993 ,proved non-cytotoxicity, non-irritating and non-sensitizing	Meet ISO10993 ,proved non-cytotoxicity, non-irritating and non-sensitizing	Same

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From the comparison we found the material of the current nose clip and the ear loop were different from the predicate device. The biocompatibility tests were conducted to both components to ensure their compliance to the ISO10993-5 and ISO10993-10. There is no new risk generated from the difference of the material.

The level of the proposed device is different from the predicate device, the main performance for level 3 surgical face mask is the requirement of Fluid Resistance, the performance has conducted and the the requirement of Level 2 and level 3 medical mask according to the ASTM F 2100.

Table 2 performance testing comparison

Item	Proposed device	Predicate device	Result
Fluid ResistancePerformance ASTMF1862	32 out of 32 per lot pass at 120 mmHg, 3non-consecutive lots tested;32 out of 32 per lot pass at 160 mmHg for 2non-consecutive lots tested;30 out of 32 per lot pass at 160 mmHg for 1 lot tested.	32 out of 32 passat 120 mmHg	Pass
ParticulateFiltrationEfficiency ASTM F2299	99.65%	99.16%	Pass
BacterialFiltrationEfficiency ASTM F2101	99.76%	99.74%	Pass
DifferentialPressure(Delta P) EN 14683Annex C	4.2 mmH2O/cm²	3.7 mmH2O/cm²	Pass
Flammability 16 CFR1610	Class 1	Class 1	Pass

G. Non-Clinical Test Conclusion

Non-clinical tests were conducted to verify that the proposed device met all design specifications as was similar to the predicate device. The test results demonstrated that the proposed device complies with the following standards and the requirements stated in the Guidance for Industry and FDA Staff: Surgical Masks - Premarket Notification [510(k)] Submission issued on March 5, 2004:

ISO 10993-5: 2009 Biological Evaluation of Medical Devices -- Part 5: Tests For In Vitro A Cytotoxicity
ISO 10993-10: 2010 Biological Evaluation of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization
ASTM F2100, Standard Specification for Performance of Materials Used In Medical Face Masks
A 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);

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EN 14683, Medical Face Masks-Requirements and Test Methods; A
ASTM F2101, Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) Of > Medical Face Mask Materials, Using A Biological Aerosol of Staphylococcus Aureus;
ASTM F2299, 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; >

	Table 3 - Biocompatibility Testing

Test Method	Purpose	Acceptance Criteria	Result
Cytotoxicity	The purpose of thebiocompatibility testing isto demonstrate thebiocompatibilityof the subject device.	Non-Cytotoxic	PASSUnder the conditions of thestudy, the device is non-cytotoxic.
Irritation		Non-Irritating	PASSUnder the conditions of thestudy, the device is non-irritating.
Sensitization		Non-Sensitizing	PASSUnder the conditions of thestudy, the device is non-sensitizing

Table 4 – Performance Testing

Test Method	Purpose	Acceptance Criteria	Result
Fluid ResistancePerformanceASTM F1862		29 out of 32 pass at120 mmHg for Level 229 out of 32 pass at160 mmHg for Level 3	PASS32 out of 32 per lot pass at 120mmHg, 3 non-consecutive lotstested;32 out of 32 per lot pass at 160mmHg for 2non-consecutive lots tested;30 out of 32 per lot pass at 160mmHg for 1 lot tested.
ParticulateFiltrationEfficiency ASTMF2299	The purpose ofthe performancetesting is to	≥ 98%	PASS3 non-consecutive lots tested,using a sample size of 32/lot.Lot1: 99.79%Lot2: 99.58%Lot3: 99.6%

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BacterialFiltrationEfficiencyASTM F2101	demonstrate thefunctionality ofthe subjectdevice.	≥ 98%	PASS3 non-consecutive lots tested,using a sample size of 32/lot.Lot1: 99.56%Lot2: 99.9%Lot3: 99.84%
DifferentialPressure (Delta P)EN 14683Annex C		< 6.0mmH2O/cm²	PASS3 non-consecutive lots tested,using a sample size of 32/lot.Lot1: 5.2 mmH2O/cm²Lot2: 3.8 mmH2O/cm²Lot3: 3.8 mmH2O/cm²
Flammability 16CFR 1610		Class 1	PASS3 non-consecutive lots tested,using a sample size of 32/lot.Class 1

H. Clinical Test Conclusion

No clinical study is included in this submission.

I. Conclusion

Based on the nonclinical tests performed, the subject device is as safe, as effective, and performs as well as the legally marketed predicate device Nantong Taiweishi Medical Technology Co., Ltd. Surgical Face Mask

( non-sterile ) .

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.