The surgical 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(s), provided non-sterile.

Device Description

The ECOMA surgical mask is composed of 3-layers and is flat-pleated. The mask materials consist of an outer layer (polypropylene spunbond, blue), filter layer (polypropylene melt blown, white), and inner layer (polypropylene spunbond, white). The three layers of the mask body are collated and sonically welded around the edges. The surgical mask contains ear loops attached by welding to secure the mask over the user's mouth and face and includes a malleable nosepiece to provide a firm fit over the nose. The surgical face mask is a single use, disposable device, provided non-sterile.

AI/ML Overview

The provided document is a 510(k) Premarket Notification for the ECOMA Level 2 Disposable Surgical Mask with Ear Loops. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than a clinical effectiveness study of the device itself. Therefore, many of the requested categories regarding human expert studies, multi-reader multi-case studies, and human-in-the-loop performance are not applicable to this type of regulatory submission for this medical device.

Here's the information extracted from the document regarding acceptance criteria and performance, as applicable:

1. Table of Acceptance Criteria and Reported Device Performance

Test Methodology	Acceptance Criteria	Reported Device Performance
ASTM F2101-Bacterial Filtration Efficiency (BFE)	≥ 98% Average BFE for all samples tested	96/96 samples passed ≥ 98% Average BFE (3 lots, 32 samples per lot with a lot size of 200,000 each)
ASTM F2299-Particulate Filtration Efficiency (PFE)	≥ 98% Average PFE for all samples tested	96/96 samples passed ≥ 98% Average PFE (3 lots, 32 samples per lot with a lot size of 200,000 each)
Differential Pressure	Samples must be < 6.0 mm H2O/cm²	96/96 samples passed differential pressure < 6.0 mm H2O/cm² (3 lots, 32 samples per lot with a lot size of 200,000 each)
ASTM F1862-Fluid Resistance	At least 29 out of 32 specimens per lot show passing results at 120 mmHg	95/96 samples passed fluid resistance at 120 mmHg (3 lots, 32 samples per lot with a lot size of 200,000 each)
16 CFR 1610-Flammability	All samples must be Class I	96/96 samples passed Class I flammability test (96/96 samples passed Class I flammability test)
Sensitization	The sample is non-sensitizing.	The device was tested in accordance with ISO 10993 and passed acceptance criteria. (Under the testing conditions, the subject surgical mask did not cause significant irritation or sensitization reaction to the test animals.)
Irritation	The sample is non-irritating.	The device was tested in accordance with ISO 10993 and passed acceptance criteria. (Under the testing conditions, the subject surgical mask did not cause significant irritation or sensitization reaction to the test animals.)
Cytotoxicity	The sample is non-cytotoxic.	The device was tested in accordance with ISO 10993 and passed acceptance criteria. (Under the testing conditions, the subject surgical mask did not show potential cytotoxicity.)

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

Sample Size for performance tests: For ASTM F2101 (BFE), ASTM F2299 (PFE), Differential Pressure, and 16 CFR 1610 (Flammability), the sample size was 96 individual samples, divided into 3 lots of 32 samples each.
Sample Size for Fluid Resistance: 96 individual samples, divided into 3 lots of 32 samples each. The acceptance criteria required at least 29 out of 32 specimens per lot to pass.
Sample Size for Biocompatibility (Sensitization, Irritation, Cytotoxicity): While a specific number of samples isn't given for these tests, the document states "The device was tested in accordance with ISO 10993 and passed acceptance criteria," and specifies results from "test animals" for sensitization and irritation. ISO 10993 standards typically define the appropriate sample sizes and methodologies for biological evaluation tests.
Data Provenance: The tests were non-clinical (laboratory-based) and conducted to evaluate the physical and biological characteristics of the mask according to recognized standards (ASTM, 16 CFR, ISO). The manufacturing location is Xianning, Hubei, China (XIANNING ECO MEDICAL ARTICLES CO., LTD.), so it can be inferred the samples originated from the manufacturer. The data is based on controlled laboratory testing, not human subject data.

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

Not applicable. These are non-clinical (laboratory-based) performance tests against established technical standards (e.g., ASTM, ISO), not studies requiring human expert adjudication or ground truth establishment based on human interpretation.

4. Adjudication method for the test set

Not applicable. These are non-clinical (laboratory-based) performance tests against established technical standards, not studies requiring human 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 is a 510(k) submission for a surgical mask, not an AI-powered diagnostic device.

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

Not applicable. This is a 510(k) submission for a surgical mask, not an AI-powered diagnostic device.

7. The type of ground truth used

The "ground truth" used for these tests are the established performance specifications derived from recognized industry standards like ASTM F2101, ASTM F2299, Differential Pressure (EN 14683), ASTM F1862, 16 CFR 1610, and biocompatibility standards (e.g., ISO 10993). The device's performance is measured against these numerical and qualitative benchmarks.

8. The sample size for the training set

Not applicable. This is a 510(k) submission for a non-AI medical device (surgical mask). There is no "training set" in the context of machine learning.

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

Not applicable. This is a 510(k) submission for a non-AI medical device.

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.

August 19, 2021

Xianning Eco Medical Articles Co., Ltd. Wei Zhou General Manager No.16,Shutai Street High-Tech Industrial Zone Xianning, Hubei 437000 China

Re: K210698

Trade/Device Name: ECOMA Disposable Surgical Mask (Ear loops) Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: July 14, 2021 Received: July 14, 2021

Dear Wei Zhou:

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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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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 (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 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,

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 (if known) K210698

Device Name

ECOMA Level 2 Disposable Surgical Mask with Ear Loops

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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Image /page/3/Picture/0 description: The image shows the word "ECOMA" in large, bold, blue letters. The letters are evenly spaced and appear to be a sans-serif font. The background is a light color, providing contrast for the blue text.

Tel: +86-715-8215222 Web:www.ecoma.com.cn Add:No.16, Shutai Street, High-Tech Industrial Zone, Xianning, China Fax:+86-715-8217333 E-mail:service@ecoma.com.cn

510(k) SUMMARY

510(k) Premarket Notification for ECOMA Level 2 Disposable Surgical Mask with Ear Loops

In accordance with the requirements set forth in Title 21 CFR §807.92

1. Submitter: XIANNING ECO MEDICAL ARTICLES CO., LTD. No.16, Shutai Street High-Tech Industrial Zone Xianning, China 437000
  Tel: +86-715-8215222 8018

Fax: +86-715-8217333 FDA Registration Number: 3008240985

1. XIANNING ECO MEDICAL ARTICLES CO., LTD. Manufacturing Location: No.16, Shutai Street High-Tech Industrial Zone Xianning, China 437000 Registration Number: 3008240985
1. Packaging Location: Same as Manufacturing Location
1. Regulatory Affairs Contact: Wei Zhou General Manager Tel: +86-715-8215222 8018 Fax: +86-715-8217333 Email: zhouwei@ecoma.com.cn ട. Date Summary Prepared: Feb-08-2021
1. Name of Device: ECOMA Level 2 Disposable Surgical Mask with Ear Loops

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Tel: +86-715-8215222 Web:www.ecoma.com.cn Add: No.16, Shutai Street, High-Tech Industrial Zone, Xianning, China Fax:+86-715-8217333 E-mail:service@ecoma.com.cn

1. Trade Name: ECOMA Level 2 Disposable Surgical Mask with Ear Loops
1. Common/Classification Name: Surgical Mask
1. Regulation Number: 21 CFR §878.4040
1. Device Class: Class II
Surgical Apparel 11. Regulation Name:
1. Product Code: FXX

Predicate Device: BH Medical Products Co., Ltd. Level 2 Surgical Mask with ear loops (K133070).

Device Description: The ECOMA surgical mask is composed of 3-layers and is flat-pleated. The mask 14. materials consist of an outer layer (polypropylene spunbond, blue), filter layer (polypropylene melt blown, white), and inner layer (polypropylene spunbond, white). The three layers of the mask body are collated and sonically welded around the edges. The surgical mask contains ear loops attached by welding to secure the mask over the user's mouth and face and includes a malleable nosepiece to provide a firm fit over the nose. The surgical face mask is a single use, disposable device, provided non-sterile.

Over the counter use: Yes

Duration and type of contact: Direct contact, less than 24 hours, skin contact Single use disposable device: Yes

Packaging: 50 masks/box
Indications for Use: The surgical 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(s), provided non-sterile.

17. Technological Characteristics Comparison:

:
For the Surgical Face Masks with Ear loops:
Surgical Face Mask with Ear Loops

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Tel: +86-715-8215222 Fax:+86-715-8217333

Web:www.ecoma.com.cn E-mail:service@ecoma.com.cn

Add:No.16, Shutai Street, High-Tech Industrial Zone, Xianning, China

K133070
Submitter of 510(K)/holder: BH Medical Products Co., Ltd ●

Technological Characteristics Comparison Table (Ear loop): 18.

Element ofComparison	Predicted DeviceK133070	Subject Device	Comparison
Manufacturer	BH Medical Products Co., Ltd	Xianning ECO MedicalArticles Co, Ltd.	N/A
Proprietary orModel Name	Surgical Face Mask, EarLoops, Model101B, 101G, 136B, 136G,137B, 137G	Surgical Face Mask, EarLoops,Model LV2001W-B	N/A
Intended Use	The surgical face masks areintended to be worn to protectboth the patient and healthcarepersonnel from transfer ofmicroorganisms, body fluids andparticulate material. Thesefacemasks are intended for usein infection control practices toreduce the potential exposure toblood and body fluids. This is asingle use, disposable device(s),provided nonsterile.	The surgical face masks areintended to be worn to protectboth the patient and healthcarepersonnel from transfer ofmicroorganisms, body fluidsandparticulate material. Thesefacemasks are intended for usein infection control practices toreduce the potential exposuretoblood and body fluids. This is asingle use, disposable device(s),provided nonsterile.	Same
ASTM Level	1, 2, 3	2	Similar
Design feature	Ear Loops and Tie on	Ear Loops	Similar
Mask styles	3 flat pleated	4 Flat pleated	Similar
ProductPerformanceSpecifications	Meet ASTM F1862-07Meet ASTM F2101-07Meet ASTM F2299-03Meet MIL-M-36954CMeet 16 CFR Part 1610	ASTM F1862/F1862-M-17Meet ASTM F2101-19and EN 14683:2019ASTM F2299/F2299M-17Meet ASTM F2100-19Meet 16 CFR Part 1610	SimilarSimilarSimilarSimilarSimilar
16 CFR Part 1610	Class 1	Class 1	similar
Single Use	Yes	Yes	same
Disposable	Yes	Yes	same
Non-sterile	Yes	Yes	Same
MaterialComposition	Three-layer mask constructedof:Outer layer: spunbondpolypropyleneFilter layer: melt blownpolypropyleneInner layer: spunbondpolypropyleneBinding: SpunbondPolypropyleneEar loops: PolyesterNose clip: Aluminum Wire	Three-layer mask constructedof:Outer layer: PolypropyleneSpunbondFilter layer: PolypropyleneMelt blownInner layer: PolypropyleneSpunbondEar loops: Spandex elastic,polyesterNose Piece: Malleable Iron wirewith plasticcover/Polypropylene	Similar
ASTM Level	1, 2, 3	2	Similar
Design feature	Ear Loops and Tie on	Ear Loops	Similar
Mask styles	3 flat pleated	4 Flat pleated	Similar
Color	Blue, Green	Blue	Same
Dimensions(L*W)	6.8" +/-0.25"x 4.2" +/-0.25"	17.5 x 9.5 cm (+/- 0.5cm)	Same
Use	Single Use; Disposable	Single Use; Disposable	Same
Biocompatibility	The surgical mask was tested inaccordance with ISO10993 andpassed acceptancecriteria.	The surgical mask was testedwithfollowing standards:• AAMI /ANSI/ ISO10993-5:2009,Under the testing conditions,the subject surgical mask didnot show potential cytotoxicity• AAMI /ANSI/ ISO10993-10:2010,Under the testing conditions,the subject surgical mask didnot cause significant irritationor sensitizationreaction to the test animals.	Same

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11

Tel: +86-715-8215222

Web:www.ecoma.com.cn

Fax:+86-715-8217333

E-mail:service@ecoma.com.cn

Add:No.16, Shutai Street, High-Tech Industrial Zone, Xianning, China

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Tel: +86-715-8215222 Fax:+86-715-8217333 Web:www.ecoma.com.cn E-mail:service@ecoma.com.cn

Add:No.16, Shutai Street, High-Tech Industrial Zone, Xianning, China

Summary of Non-Clinical Testing (ASTM F2100 Performance Testing and Biocompatibility Testing Results) 19.

Test Methodology	Purpose	Acceptance Criteria	Test Results
ASTM F2101-Bacterial FiltrationEfficiency (BFE)	To measure the bacterialfiltration efficiency (BFE) ofmedical face mask materials,employing a ratio of theupstream bacterial challengeto downstream residualconcentration to determinefiltration efficiency of medicalface mask materials.	≥ 98% Average BFEfor all samples tested	96 /96 samples passed ≥ 98% Average BFE (3 lots, 32samples per lot with a lot sizeof 200,000 each)
ASTM F2299-ParticulateFiltrationEfficiency	To determine the InitialEfficiency of MaterialsUsed in Medical FaceMasks to Penetration byParticulates Using Latex.Spheres	≥ 98% Average PFEfor all samples tested	96 /96 samples passed ≥ 98% Average PFE (3 lots, 32samples per lot with a lot sizeof 200,000 each)
Differential Pressure	To determine the pressurerequired to breathe throughthe final manufactured facemask	Samples must be <$6.0 mm H_2O/cm^2$	96 /96 samples passeddifferential pressure < $6.0 mm H_2O/cm^2$ (3 lots, 32samples per lot with a lotsize of 200,000 each)
ASTM F1862-FluidResistance	To evaluate theresistance of medicalface masks topenetration by theimpact of a small volume(~2mL) of a high-velocitystream of syntheticblood.	At least 29 out of 32specimens per lotshow passing resultsat 120 mmHg	95 /96 samples passed fluidresistance at 120 mmHg (3lots, 32 samples per lot witha lot size of 200,000 each)
16 CFR1610-Flammability	The purpose of this standard isto reduce danger of injury andlossof life by providing, on anational basis, standardmethods of testing and ratingthe flammability of textiles andtextile products for clothinguse, thereby prohibiting theuse of any dangerously	All samples must beClass I	96 /96 samples passed Class Iflammability test (96 /96samples passed Class Iflammability test )

Sensitization	Under the research conditions,determine whether the non-polar and polar extracts of thetarget device are irritating.	The sample is non-sensitizing.	The device was tested inaccordance with ISO 10993and passed acceptancecriteria
Irritation	Under the research conditions,determine whether the non-polar and polar extracts of thetarget device are sensitive.	The sample is non-irritating.
Cytotoxicity	Under the research conditions,determine whether the targetdevice extract is cytotoxic.	The sample is non-cytotoxic.

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Tel: +86-715-8215222 Fax:+86-715-8217333

Web:www.ecoma.com.cn E-mail:service@ecoma.com.cn

Add:No.16, Shutai Street, High-Tech Industrial Zone, Xianning, China

20. Conclusion

The conclusion drawn from the nonclinical tests demonstrate that the subject device is as safe, as effective, and performs as well as or better than the legally marketed predicate device, BH Medical Products Surgical Face Mask cleared under K133070.

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.