The Medical Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. The medical surgical mask is 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 Medical Surgical Masks are blue color, three-layer, flat-pleaded masks with nose piece and ear loops, which are composed of inner layer and outer layer. The colorant is blue polypropylene (PP) master batch. The inner layer and outer layer of the mask are made of non-woven fabric (polypropylene), the middle layer is made of melt-blown fabric (polypropylene). The ear loop of the subject mask is held in place over the users' mouth and nose by two ear loops welded to the face mask. The ear loop is made with polyamide and spandex. The nose piece in the layers of face mask is to allow the user to fit the mask around their nose, which is made of polypropylene wrapped galvanized soft wire. The Medical Surgical Mask is sold non-sterile and are intended to be single use, disposable devices. The mask is designed and manufactured in accordance with ASTM F2100-19 Standard Specification for Performance of Materials Used in Medical Face Masks.

AI/ML Overview

This document is a 510(k) premarket notification for a Medical Surgical Mask (Planar type). It focuses on demonstrating substantial equivalence to a predicate device, as required by the FDA. The performance data presented is for the device itself, not an AI/ML algorithm. Therefore, many of the requested categories related to AI/ML clinical studies are not applicable.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The device is a Medical Surgical Mask, and its performance is evaluated against parameters specified in medical device standards such as ASTM F2100. The acceptance criteria and reported performance are for the physical properties and barrier effectiveness of the mask.

Test Methodology	Purpose	Acceptance Criteria (for Level 3 Barrier)	Reported Device Performance (for 3 non-consecutive lots, sample size 32/lot)
Bacterial Filtration Efficiency (ASTM F2101)	Measure bacterial filtration efficiency	≥98%	Passed: Lot 1: ≥98%, Lot 2: ≥98%, Lot 3: ≥98%
Differential Pressure (mmH2O/cm²) (EN 14683:2019 Annex C)	Determine breathability of the mask	<6.0 mmH2O/cm²	Passed: Lot 1: <6.0, Lot 2: <6.0, Lot 3: <6.0
Sub-micron Particulate Filtration Efficiency (ASTM F2299-17)	Measure initial particle filtration efficiency	≥98%	Passed: Lot 1: ≥98%, Lot 2: ≥98%, Lot 3: ≥98%
Resistance to Penetration by Synthetic Blood (ASTM F1862-17)	Evaluate the resistance to penetration by impact of small volume of synthetic blood	29 out of 32 pass at 160 mmHg	Passed: Lot 1: 32 out of 32 pass at 160 mmHg, Lot 2: 32 out of 32 pass at 160 mmHg, Lot 3: 32 out of 32 pass at 160 mmHg
Flammability (16 CFR Part 1610-2008)	Response of materials to heat and flame	Class I	Passed: Lot 1: Class 1, Lot 2: Class 1, Lot 3: Class 1
Cytotoxicity (ISO 10993-05)	Assess the potential risk of cytotoxicity of mask material	Non-cytotoxic	Pass: Under the condition of this study, the device has no potential toxicity.
Irritation (ISO 10993-10)	Assess the potential risk of irritation of mask material	Negligibly irritating	Pass: Under the condition of this study, the device is negligibly irritating.
Sensitization (ISO 10993-10)	Assess the potential risk of sensitization of mask material	Non-sensitizing	Pass: Under the conditions of the study, the device is non-sensitizing.

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

The sample size for performance testing was 32 units per lot, across 3 non-consecutive lots. This makes a total of 96 units tested for each performance characteristic.

Data provenance is from non-clinical tests conducted by Hunan Chopard Medical Devices Co., Ltd., based in Hunan Province, China. The tests are retrospective to the manufacturing process, as they are performed on finished product lots.

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

Not applicable. This is not an AI/ML device requiring expert ground truth for image interpretation or diagnosis. The tests are laboratory-based measurements of physical and biological properties.

4. Adjudication method for the test set

Not applicable. There is no expert adjudication for these non-clinical, objective tests. The results are quantitative measurements against predefined criteria.

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 is not an AI/ML device, and no human reader studies or MRMC studies were performed.

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

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

7. The type of ground truth used

The "ground truth" for the device's performance is established by validated laboratory testing methods against published international and national standards (e.g., ASTM F2101, EN 14683, ASTM F1862, ISO 10993). These standards define objective, measurable criteria for the performance of medical surgical masks.

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. As there is no AI/ML component, there is no training set or ground truth in that context.

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.

May 19, 2022

Hunan Chopard Medical Devices Co., Ltd % Ivy Wang Technical Manager Shanghai Sungo Management Consulting Company Limited 14th Floor, 1500# Century Avenue Shanghai. 200122 China

Re: K220824

Trade/Device Name: Medical Surgical Mask (Planar type) Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: March 21, 2022 Received: March 21, 2022

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 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,

Brent Showalter, Ph.D. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic 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) K220824

Device Name Medical Surgical Mask (Planar type)

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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510(K) Summary

(As requirement by 21 CFR 807.92)

Date prepared: 19th, May, 2022

A. Applicant:

Name: Hunan Chopard Medical Devices Co., Ltd Address: 88, Tongxin Road, Longfu Town Industrial District, Liuyang City, Hunan Province Contact: Wei Hongwei Title: Management Representative Tel: +86- 13225896000 Email: chopard@vip.163.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:

Trade Name: Medical Surgical Mask (Planar type) Common Name: Surgical Mask Model: Planar type

Regulatory Information Classification Name: Surgical Face Mask Classification: Class II Product code: FXX Regulation Number: 21 CFR 878.4040 Review Panel: Surgical Apparel

C. Identification of Primary Predicate device:

K211827 Zhejiang Lanhine Medical Products LTD. Trade Name: Level 3 Fluid Resistant Procedure/Surgical Mask Common Name: Surgical Face Mask Model(s): 15604F, 15704F

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

D. Indications for use of the device:

E. Device Description:

The inner layer and outer layer of the mask are made of non-woven fabric (polypropylene), the middle layer is made of melt-blown fabric (polypropylene). The ear loop of the subject mask is held in place over the users' mouth and nose by two ear loops welded to the face mask. The ear loop is made with polyamide and spandex. The nose piece in the layers of face mask is to allow the user to fit the mask around their nose, which is made of polypropylene wrapped galvanized soft wire.

The Medical Surgical Mask is sold non-sterile and are intended to be single use, disposable devices.

The mask is designed and manufactured in accordance with ASTM F2100-19 Standard Specification for Performance of Materials Used in Medical Face Masks.

F. Comparison of technological characteristics with the predicate device

The medical surgical masks are essentially the same as or similar to the predicate device in terms of the indications for use, design and construction, performance characteristics. Provided below table 1 is a comparison of the proposed device with the predicate device.

Device	Proposed Device	Predicate Device	Result
510K #	-	K211827	-
Manufacturer	Hunan Chopard Medical Devices Co., Ltd	Zhejiang Lanhine Medical Products LTD.	-
Product Name	Medical Surgical Mask	Level 3 Fluid Resistant Procedure/Surgical Mask	Similar

Table 1 Comparison of Proposed and Predicate Devices

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Hunan Chopard Medical Devices Co., Ltd 88, Tongxin Road, Longfu Town Industrial District, Liuyang City, Hunan Province

Level	Level 3	Level 3	Same
Product Code	FXX	FXX	Same
RegulationNumber	21 CFR 878.4040	21 CFR 878.4040	Same
Indications foruse	The Medical Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. The medical surgical mask is 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.	The Level 3 Fluid Resistant Procedure/Surgical Masks (model: 15604F, 15704F) 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.	Same
Design Feature	Ear loops, flat pleated, 3 layers	Ear loops, tie-on, flat pleated, 3 layers	Similar
Color	Blue	Blue	Same
Dimension	Length: 17.5cm ± 5%Width: 9.5cm ± 5%	17.5cm ± 0.5cm9.5cm ± 0.5cm	Similar
Sterility	Non-sterile	Non-sterile	Same
Use	Single Use, Disposable	Single Use, Disposable	Same
Material
Outer layer	Non-woven fabric(Polypropylene)	Non-woven fabric(Polypropylene)	Same
Middle layer	Melt blown fabric(Polypropylene)	Melt blown fabric(Polypropylene)	Same
Inner layer	Non-woven fabric(Polypropylene)	Non-woven fabric(Polypropylene)	Same
Nose clip	Polypropylene wrapped galvanized soft wire	Polypropylene coating iron	Different
Ear loops	polyamide and spandex	Polyurethane	Different
Biocompatibility	ISO 10993	ISO 10993	Same

Difference Analysis:

The proposed device has different material of nose clip and ear loops to the predicate device. However, biocompatibility test has been performed on the proposed device according to ISO 10993-10 and the results do not show any adverse effect. Thus, this difference will not affect the safety and effectiveness between the proposed device and the predicate device.

G. Summary of Non-Clinical Testing

Non-clinical tests were conducted to verify that the proposed device met all design specification. The test results demonstrated that the proposed device complies with the following standards and the requirements

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stated in the Guidance for Industry and FDA Staff: Surgical Mask - Premarket Notification [510(K)] Submission issued on March 5, 2004:

ISO 10993-05:2009 Biological Evaluation of Medical Devices Part 5: Tests for In Vitro Cytotoxicity A
ISO 10993-10:2010 Biological Evaluation of Medical Devices Part 10: Tests for Irritation And Skin A Sensitization
A ASTM F2100, Standard Specification for Performance of Materials Used in Medical Face Masks
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)
EN 14683, Medical Face Masks - Requirements and Test Methods
ASTM F2101, Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus Aureus
A ASTM F2299, Standard Test Method for Determining the Initial Efficiency of Materials Used in Medical Face Masks to Penetration by Particulates Using Latex Spheres
A 16 CFR 1610, Standard for the Flammability of Clothing Textiles

Performance testing and biocompatibility testing are summarized in below table 2.

Test Methodology	Purpose	Acceptance Criteriafor Level 3 Barrier	Result
Bacterial FiltrationEfficiencyASTM F2101	Measure bacterialfiltration efficiency	≥98%	Passed3 non-consecutive lots tested, using asample size of 32/lotLot 1: ≥98%Lot 2:≥98%Lot 3:≥98%
DifferentialPressure(mmH2O/cm²)EN 14683:2019Annex C	Determinebreathability of themask	<6.0 mmH2O/cm²	Passed3 non-consecutive lots tested, using asample size of 32/lotLot 1: <6.0Lot 2: <6.0Lot 3: <6.0
Sub-micronParticulateFiltrationEfficiency ASTMF2299-17	Measure initialparticle filtrationefficiency	≥98%	Passed3 non-consecutive lots tested, using asample size of 32/lotLot 1: ≥98%Lot 2: ≥98%Lot 3: ≥98%
ResistancetoPenetrationbySynthetic BloodASTM F1862-17	Evaluate theresistance topenetration byimpact of smallvolume of syntheticblood	29 out of 32 pass at 160mmHg	Passed3 non-consecutive lots tested, using asample size of 32/lotLot 1: 32 out of 32 pass at 160 mmHgLot 2:32 out of 32 pass at 160 mmHgLot 3:32 out of 32 pass at 160 mmHg

Table 2: Summary of Performance Testing & Biocompatibility testing

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Flammability16 CFR Part1610-2008	Response ofmaterials to heatand flame	Class I	Passed3 non-consecutive lots tested, using asample size of 32/lotLot 1: Class 1Lot 2: Class 1Lot 3: Class 1
Cytotoxicity	Assess the potentialrisk of cytotoxicityof mask material	Non-cytotoxic	PassUnder the condition of this study, thedevice has no potential toxicity.
Irritation	Assess the potentialrisk of irritation ofmask material	Negligibly irritating	Under the condition of this study, thedevice is negligibly irritating.
Sensitization	Assess the potentialrisk of sensitizationof mask material	Non-sensitizing	Under the conditions of the study, thedevice is non-sensitizing

H. Clinical Test Conclusion

No clinical study is included in this submission.

I. Conclusion

The conclusion drawn from the nonclinical tests demonstrates that the subject device in 510(K) submission, the Medical Surgical Mask is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K211827.

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.