The Surgical Face Mask is intended for single use by operating room personnel and other general healthcare workers to protect both patients and healthcare workers against transfer of microorganisms, blood and body fluids, and particulate materials.

Device Description

The proposed device, is a three-layer, single-use, flat-pleated mask. The inner and outer layers of the mask are made of spun-bonded nonwoven polypropylene, and the middle layer is made of melt-blown nonwoven polypropylene. The proposed devices are available in two types, ear-loop and Tie-on. The ear loops are made of nylon and spandex, and the ties are made of spun-bonded nonwoven polypropylene. The ear loops/tie-on is held in place over the users' mouth and nose by ear loops/ties welded to the mask. The nose clip is made of Medical polypropylene+Q235. Users can adjust the nose clip according to the shape of the bridge of the nose, and fix the mask on the bridge of the nose to prevent the mask from falling off. Both the ear loop and tie-on masks are available in different sizes to provide more options for user. The proposed device can be provided in sterile and non-sterile two types.

AI/ML Overview

The document you provided is a 510(k) Premarket Notification for Surgical Face Masks. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving that a device meets specific acceptance criteria through a clinical or standalone study.

Therefore, the information requested in your prompt (acceptance criteria, details of a study proving device performance, sample sizes, expert involvement, ground truth establishment, etc.) is not present in this document. This 510(k) primarily relies on non-clinical performance testing and a comparison of technological characteristics to a predicate device.

Specifically:

No clinical study was conducted or included in this submission. The document explicitly states this in Section 7: "No clinical study is included in this submission."
The "acceptance criteria" for a 510(k) are typically met by demonstrating that the new device performs "as well as" or "better than" the predicate device in relevant non-clinical tests or by meeting recognized consensus standards. The document shows tables of test results (e.g., Bacterial Filtration Efficiency, Particulate Filtration Efficiency, Fluid Resistance) against, or in comparison to, the predicate device and relevant standards (e.g., ASTM F2100 Level 2).
There is no mention of human experts establishing ground truth for a test set, adjudication methods, or MRMC studies because there was no clinical study.

However, I can extract information related to the device performance and testing that was done to support the 510(k) clearance, framed as "reported device performance" against relevant "acceptance criteria" derived from the standards and predicate comparison:

The provided 510(k) Premarket Notification for Surgical Face Masks (K202843) demonstrates substantial equivalence to a predicate device (K173062) by relying on non-clinical performance testing rather than a clinical study. Therefore, the concept of "acceptance criteria" and a "study that proves the device meets the acceptance criteria" in the context of human data, expert adjudication, or MRMC studies is not applicable to this submission.

Instead, the device meets "acceptance criteria" by demonstrating performance in laboratory tests in accordance with recognized consensus standards (e.g., ASTM F2100 Level 2) and by showing that its technological characteristics are substantially equivalent to the predicate device.

Here's an interpretation of the requested information based on the provided document, focusing on the non-clinical testing performed:

1. Table of Acceptance Criteria (as per standards/predicate comparison) and Reported Device Performance:

Performance Characteristic	Acceptance Criteria (based on ASTM F2100 Level 2 or predicate)	Reported Device Performance (K202843)
Fluid Resistance	Pass at 120 mmHg (Same as Predicate)	Pass at 120 mmHg
Particulate Filtration Efficiency (PFE)	Meet requirements for Level 2 (~98.98% for predicate) - Note: ASTM F2100 Level 2 minimum PFE is ≥ 98% at 0.1 µm.	Average 98.98%
Bacterial Filtration Efficiency (BFE)	Meet requirements for Level 2 (~99.4% for predicate) - Note: ASTM F2100 Level 2 minimum BFE is ≥ 98%.	Average 98.92%
Differential Pressure (Delta P)	Meet requirements for Level 2 (Average 2.7 $mmH_2O/cm^2$ for predicate) - Note: ASTM F2100 Level 2 maximum Delta P is < 5.0 $mmH_2O/cm^2$.	Average 4.4 $mmH_2O/cm^2$
Flammability	Class 1 (Same as Predicate)	Class 1
Biocompatibility	Non-cytotoxic, non-sensitizing, and non-irritating (Based on ISO 10993-5 and ISO 10993-10, same as Predicate)	Non-cytotoxic, non-sensitizing, and non-irritating
Sterilization Effectiveness	Effective sterilization validated per ISO 11135 (for sterile version only)	Demonstrated effective sterilization (for sterile version)
Seal Integrity	Meet standard for determining integrity/detecting seal leaks (ASTM F1886/F1886M-16, ASTM F1929-15, ASTM F88/F88M-15)	Complies with relevant ASTM standards
Initial Efficiency of Material	Meet standard for determining initial efficiency using latex spheres (ASTM F2299/F2299M-03 (2017))	Complies with relevant ASTM standard
Resistance to Synthetic Blood	Meet standard for resistance to penetration by synthetic blood (ASTM F1862/F1862M-17)	Complies with relevant ASTM standard

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

Sample Size: Not explicitly stated for each test, but general non-clinical testing typically involves a sufficient number of samples to ensure statistically valid results based on the specific test standard.
Data Provenance: The tests were conducted by a Chinese company (B.J.ZH.F.Panther Medical Equipment Co., Ltd) and are presumably laboratory tests on manufactured device samples. The document doesn't specify if the testing was done in China or elsewhere, but it is implied to be non-clinical, in-vitro/bench testing.
Retrospective/Prospective: Not applicable to non-clinical bench testing.

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

Not applicable. Ground truth for these types of non-clinical tests is established by adhering to the specified methodology and validated equipment outlined in the respective ASTM or ISO standards. There is no human "expert" adjudication in terms of clinical interpretation for this type of submission.

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

Not applicable. There was no clinical study with human readers requiring adjudication.

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 device is a surgical face mask, not an AI-powered diagnostic tool. No MRMC study was performed.

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

Not applicable. This device is a physical medical device (surgical face mask), not an algorithm or software. Its performance is inherent to its physical properties and material science.

7. The type of ground truth used:

For physical properties and material performance: Ground truth is defined by the validated methodologies and performance specifications within recognized consensus standards (e.g., ASTM, ISO standards) for testing medical face masks. Biocompatibility "ground truth" is based on the biological response observed following testing as per ISO 10993 standards.

8. The sample size for the training set:

Not applicable. This refers to AI/machine learning models.

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

Not applicable. This refers to AI/machine learning models.

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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.

January 12, 2021

B.J.ZH.F.Panther Medical Equipment Co., Ltd % Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O. Box. 120-119 Shanghai. 200120 China

Re: K202843

Trade/Device Name: Surgical Face Masks (Sterile), Surgical Face Masks (Non-sterile) Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: September 21, 2020 Received: August 17, 2020

Dear Diana Hong:

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 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR

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 (OS) 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.

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K202843

Device Name

Surgical Face Masks (Non-sterile), Surgical Face Masks (Sterile)

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

This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92.

The assigned 510(k) Number: K202843

1. Date of Preparation: 01/12/2021
1. Sponsor Identification

B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., LTD

Floor 3, Building 1, 28 Huoju Street, Changping Science and Technology Park, Changping District, 102200 Beijing, China.

Establishment Registration Number: 3008388437.

Contact Person: Jiahui Li Position: International Regulatory Affair Tel: +86-10-80789058-6107 Fax: +86-10-69707402-8068 Email: jiahui.li@pantherhealthcare.com

1. Designated Submission Correspondent
  Ms. Diana Hong (Primary Contact Person) Ms. Ying Xu (Alternative Contact Person)

Mid-Link Consulting Co., Ltd. P.O. Box 120-119, Shanghai, 200120, China

Tel: +86-21-22815850, Fax: +1-360-925-3199 Email: info@mid-link.net

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4. Identification of Proposed Device

Trade Name: Surgical Face Masks (Sterile), Surgical Face Masks (Non-sterile) Common Name: Surgical Face Mask

Regulatory Information Classification Name: Mask, Surgical Classification: II; Product Code: FXX: Regulation Number: 21CFR 878.4040 Review Panel: General Hospital

Indication for use:

Device Description:

The proposed device, is a three-layer, single-use, flat-pleated mask. The inner and outer layers of the mask are made of spun-bonded nonwoven polypropylene, and the middle layer is made of melt-blown nonwoven polypropylene. The proposed devices are available in two types, ear-loop and Tie-on. The ear loops are made of nylon and spandex, and the ties are made of spun-bonded nonwoven polypropylene. The ear loops/tie-on is held in place over the users' mouth and nose by ear loops/ties welded to the mask. The nose clip is made of Medical polypropylene+Q235. Users can adjust the nose clip according to the shape of the bridge of the nose, and fix the mask on the bridge of the nose to prevent the mask from falling off. Both the ear loop and tie-on masks are available in different sizes to provide more options for user, which was provided in following table. The proposed device can be provided in sterile and non-sterile two types.

Model	Ear loop	Tie-on	Size (mm)
KWE-14.5×9 (Sterile)	√		145×90
KWE-17.5×9.5 (Sterile)	√		175×95
KWB-14.5×9 (Sterile)		√	145×90
KWB-17.5×9.5 (Sterile)		√	175×95
KWE-14.5×9 (Non-sterile)	√		145×90
KWE-17.5×9.5 (Non-sterile)	√		175×95
KWB-14.5×9 (Non-sterile)		√	145×90
KWB-17.5×9.5 (Non-sterile)		√	175×95

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1. Identification of Predicate Device
  510(k) Number: K173062 Product Name: NonWoven Face Mask

6. Non-Clinical Test Conclusion

Non clinical tests were conducted to verify that the proposed device met all design specifications as was same/similar to the predicate device. The test results demonstrated that the proposed device complies with the following standards:

ISO 10993-5:2009 Biological evaluation of medical device- Part 5: Tests for in vitro cytotoxicity;
ISO 10993-10:2010 Biological evaluation of medical device- Part 10: Tests for irritaion and skin sensitization;
ASTM F1886/F1886M-16 Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection;
A ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration;
ASTM F88/F88M-15 Standard Test Method for Seal Strength of Flexible Barrier Materials;
A ASTM F2299/F2299M-03 (2017) Standard Test Method for Determining the Initial Efficiency of Material Used in medical Face Masks to Penetration by Particulates using Latex Spheres;
ASTM F2101-2019 Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus;
ASTM F1862/F1862M-17 Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity);
16 CFR Part 1610 Standard for the Flammability of Clothing Textiles;
EN 14683: 2019 Medical face masks- Requirements and test methods
A ISO 10993-7:2008 Biological Evaluation of Medical Device- Part 7: Ethylene Oxide Sterilization Residuals
Clinical Test Conclusion 7.

No clinical study is included in this submission.

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8. Summary of Technological characteristics

ITEM	Proposed Device	Predicate Device	Remark
510(k) Number	K202843	K173062	/
Product Code	FXX	FXX	Same
Regulation No.	21 CFR 878.4040	21 CFR 878.4040	Same
Class	II	II	Same
Indication for Use	The Surgical Face Mask is intended forsingle use by operating room personneland other general healthcare workers toprotect both patients and healthcareworkers against transfer ofmicroorganisms, blood and body fluids,and particulate materials.	Non Woven Face Mask (Models:VQN0185W (earloop) andVQN0185B (ties)) is intended forsingle use by operating roompersonnel and other generalhealthcare workers to protect bothpatients and healthcare workersagainst transfer of microorganisms,blood and body fluids, andparticulate materials.	Same
Mask style	Flat-pleated, 3 layers	Flat-pleated, 3 layers	Same
Design feature	Ear loop/Tie-on	Ear loop/Tie-on	Same
Color	Blue	Blue	Same
Dimension	1.14.5cm×9cm:Nose Clip: 85mm×2.9mmEar Loop: 180mm×3mmTies: 910mm×10mm2.17.5cm×9.5cm:Nose Clip: 100mm×2.9mmEar Loop: 180mm×3mmTies: 910mm×10mm	17.5cm×9.5cm	Different
ASTM F2100 Level	Level 2	Level 2	Same
Sterility	Sterile/Non-sterile	Non-sterile	Different
Use	Single Use, Disposable	Single Use, Disposable	Same
Fluid resistance	Pass at 120mmHg	Pass at 120mmHg	Same
Particulatefiltrationefficiency	Average 98.98%	Average 99.74% at 0.1μm	Similar
Bacterialfiltrationefficiency	Average 98.92%	Average 99.4%	Similar
Differential pressure	Average 4.4 $mmH_2O/cm^2$	Average 2.7 $mmH_2O/cm^2$	Similar
Flammability	Class 1	Class 1	Same
Label/Labeling	Complied with 21 CFR part 801	Complied with 21 CFR part 801	Same
Patient Contacting Material
Outer facing layer	Spun-bonded nonwoven polypropylene	Spun-bond polypropylene
Middle layer	Melt-blown nonwoven polypropylene	Melt blown polypropylene filter
Inner facing layer	Spun-bonded nonwoven polypropylene	Spun-bond polypropylene
nose clip	Medical polypropylene and Q235	Malleable aluminum wire	Different
Ear loops	Nylon and spandex	Polyester
Tie-on	Spun-bonded nonwoven polypropylene	Spun-bond polypropylene
Biocompatibility	ISO 10993-5 and ISO 10993-10;Under the conditions of the study, theproposed device extract was determinedto be non-cytotoxic, non-sensitizing,and non-irritating.	ISO 10993-5 and ISO 10993-10;Under the conditions of the study,the proposed device extract wasdetermined to be non-cytotoxic,non-sensitizing, and non-irritating.	Same

Table 1 Comparison of Surgical Face Masks

4 / 6

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Different- Dimension

The dimension for proposed device is different from predicate device. The proposed device provides more dimension options, which can allow users to choose the appropriate dimension of masks according to their needs. In addition, the different size does not affect the indication for use.

Different- Sterility

The proposed device can be provided in sterile. The proposed non-sterile mask is same as the predicate device, while the sterile mask is not covered by the predicate device. However, the sterilization process were validated per ISO 11135 and the result demonstrated that the sterilization process is effective. In addition, the performance test and biocompatibility test were also conducted on the sterilized mask and the test result demonstrated that the device can meet the requirements of level 2 mask and does not raise any adverse effects after sterilization.

Similar -Particulate filtration efficiency

The test result for particulate filtration efficiency for the proposed device is different from predicate device. However, the test result for the proposed device can meet the requirements of level 2 mask.

Similar - Bacterial filtration efficiency

The test result for bacterial filtration efficiency for the proposed device is different from predicate device. However, the test result for the proposed device can meet the requirements of level 2 mask.

Similar - Differential pressure

The test result for different pressure for the proposed device is different from predicate device. However, the test result for the proposed device can meet the requirements of level 2 mask.

Different- Patient Contacting Material

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The patient contacting material for the proposed device is different from predicate device. However, biocompatibility test has been performed on the proposed device and the results does not show any adverse effect.

1. Conclusion
  The subject device is a safe, as effective, and perform as well as the legally marketed predicate device K173062 Non Woven Face Mask.

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.