Disposable Medical Face Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. This face mask is intended for use in infection control practices to reduce the potential exposure of the wearer to blood and body fluids. The mask is a single use, disposable device, provided non-sterile.

Device Description

The Disposable Medical Face Mark is blue color, and flat pleated type mask, utilizing ear loops or tie-on way for wearing, and has nose strip design for fitting the facemask around the nose. The colorant used in the mask outer layer is blue: Copper phthalocyanine/ CAS number: 147-14-8). The proposed device is manufactured with three layers, the inner and outer layers made of spunbond polypropylene, and the middle layer is made of melt blown polypropylene filter. The model DY 96, tie-on, is held in place over the user's mouth and nose by four straps welded to the facemask. The straps are made of Spun-bond polypropylene. Its dimension is 17.5x9.5cm, strap is 38 cm, nose strip is 9.5±0.5 cm.

The models MK-34, DY 95 and DY 97, ear loops, are held in place over the user's mouth and nose by two elastic ear loops welded to the facemask. The elastic ear loops are made of Nylon and Spandex, not made with natural rubber latex. The dimension of MK-34 is 14.5x9.5cm, ear loop is 13cm, nose strip is 9.5±0.5 cm. The dimension of DY 95 and DY 97 is 17.5x9.5cm, ear loop is 13 cm, nose strip is 9.5±0.5 cm.

The nose strip contained in the proposed device is in the layers of facemask to allow the user to fit the facemask around their nose, which is made of PE and galvanized iron wire.

The device is sold non-sterile and are intended to be single use, disposable device.

AI/ML Overview

This document is a 510(k) premarket notification for a Disposable Medical Face Mask, not a study describing the performance of a medical device against specific acceptance criteria in the context of an AI/human reader study. Therefore, most of the questions regarding acceptance criteria and study design for AI/human performance are not applicable.

However, I can extract the acceptance criteria and reported performance for the Disposable Medical Face Mask based on non-clinical testing of the physical characteristics of the mask.

Here's the information based on the provided text, focusing on the mask's non-clinical performance and not on AI/human reader studies.

1. A table of acceptance criteria and the reported device performance

Test Item	Acceptance Criteria (ASTM F2100 Level 2)	Reported Device Performance (MK-34, DY 95, DY 97)	Reported Device Performance (DY 96)	Met Criteria?
Bacterial Filtration Efficiency (BFE)	≥ 98%	99.8%	99.9%	Yes
Differential Pressure (Delta-P)	< 6.0 mm H2O/cm²	4.2 mm H2O/cm²	4.0 mm H2O/cm²	Yes
Particulate Filtration Efficiency (PFE) at 0.1 µm	≥ 98%	98.9%	99.3%	Yes
Synthetic Blood Penetration	Resistant claimed at 120 mm Hg	Pass at 120 mm Hg	Pass at 120 mm Hg	Yes
Flammability	Class 1	Class 1	Class 1	Yes
Cytotoxicity	Non-cytotoxic	Non-cytotoxic	Non-cytotoxic	Yes
Irritation	Non-irritating	Non-irritating	Non-irritating	Yes
Sensitization	Non-sensitizing	Non-sensitizing	Non-sensitizing	Yes

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify the exact sample sizes used for each non-clinical performance test (e.g., how many masks were tested for BFE, PFE, etc.). It only provides the results for the different models of the mask. The data provenance is testing conducted for Guangzhou Mei Yi Kang Medical Technology CO., LTD. in China. The tests are non-clinical and relate to product performance, not patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This question is not applicable. The "ground truth" for this device (a medical face mask) is established by standardized laboratory test methods (e.g., ASTM F2101-14, EN 14683: 2019, ASTM F2299-03, 16 CFR Part 1610, ISO 10993). These are objective measurements performed in a laboratory setting, not based on expert interpretation of medical images or patient outcomes.

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

This question is not applicable. Adjudication methods like 2+1 or 3+1 refer to agreement among experts to establish ground truth in diagnostic studies. The tests conducted for this device are laboratory-based physical and biological performance tests, not diagnostic interpretations requiring expert consensus.

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

This question is not applicable. This document is for a Disposable Medical Face Mask, not an AI-powered diagnostic device, and therefore no MRMC study was performed.

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

This question is not applicable. This device is not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the non-clinical performance of the medical face mask is established by standardized laboratory test methods against predefined performance metrics (e.g., Bacterial Filtration Efficiency, Differential Pressure, Particulate Filtration Efficiency, Synthetic Blood Penetration, Flammability, and Biocompatibility tests according to ISO 10993 standards). These are objective measurements rather than interpretations requiring expert consensus or pathology.

8. The sample size for the training set

This question is not applicable. This document pertains to the performance testing of a physical medical device (face mask), not an AI algorithm. There is no concept of a "training set" in this context.

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

This question is not applicable, as there is no training set for a physical medical device.

Summary

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April 22, 2021

Guangzhou Mei Yi Kang Medical Technology CO., LTD. % Cassie Lee Official Correspondent Share Info (Guangzhou) Medical Consultant Ltd. No. 1919-1920, Building D3, Minjie Plaza, Shuixi Road, Huangpu District Guangzhou, China, zip code 510000 Tel: +86 20 8200 6973 Email: regulatory@glomed-info.com

Re: K203646

Trade/Device Name: Disposable Medical Face Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: March 31, 2021 Received: April 5, 2021

Dear Cassie Lee:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about 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 Ryan Ortega, Ph.D. Acting 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) K203646

Device Name Disposable Medical Face Mask

Indications for Use (Describe)

Models: MK-34, DY 95, DY 96, DY 97

Type of Use (Select one or both, as applicable)

	Tenant-occupied property
	Owner-occupied property

| | 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 for K203646

This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92.

1. Submitter's Information

Sponsor Name: GUANGZHOU MEI YI KANG MEDICAL TECHNOLOGY CO., LTD. Address: No.43-31 Baofeng East Road,JinShi North Avenue, Shiling Town, Huadu District, Guangzhou City, Guangdong Province, China. Post Code: 510800 Contact name: Luo Yonghui Tel: 020-22682888 E-mail: deyce988@deyce.cn

Application Correspondent:

Contact Person: Ms. Cassie Lee Share Info (Guangzhou) Medical Consultant Ltd. Address: No. 1919-1920, Building D3, Minjie Plaza, Shuixi Road, Huangpu District, Guangzhou, China Tel: +86 20 8200 6973 Email: regulatory@glomed-info.com

2. Date of the summary prepared: April 21, 2021

3. Subject Device Information

Type of 510(k): Traditional Classification Name: Mask, Surgical Common name: Surgical Mask Trade Name: Disposable Medical Face Mask Model Name: MK-34, DY 95, DY 96, DY 97 Review Panel: Surgical Apparel Product Code: FXX Requlation Number: 878.4040 Regulatory Class: II

4. Predicate Device Information

Predicate Device:

Sponsor: Skypro Medical Supplies Company

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Trade Name: Skypro, SP01 Mask Classification Name: Mask, Surgical Common name: Surgical Mask 510(K) Number: K152197 Review Panel: Surgical Apparel Product Code: FXX Regulation Number: 878.4040 Regulatory Class: II

5. Device Description

The nose strip contained in the proposed device is in the layers of facemask to allow the user to fit the facemask around their nose, which is made of PE and galvanized iron wire.

The device is sold non-sterile and are intended to be single use, disposable device.

Model	Materials	Contactclassification	colorants	Size	Styledifferences
MK-34	Outer layer:spunbondpolypropylene,Inner layer: meltblown polypropylene,Nose strip: PE andgalvanized iron wire,Ear loops: Nylon andSpandex	Less than24 hours	Copperphthalocyanine/CAS number:147-14-8).	145x95mm	Ear loop style,the ear loop iswelded on theouter layer.

The difference between the 4 models as below:

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DY 95	Outer layer:spunbondpolypropylene,Inner layer: meltblown polypropylene,Nose strip: PE andgalvanized iron wire,Ear loops: Nylon andSpandex	Less than24 hours	Copperphthalocyanine/CAS number:147-14-8).	175x95mm	Ear loop style,the ear loop iswelded on theouter layer.
DY 96	Outer layer:spunbondpolypropylene,Inner layer: meltblown polypropylene,Nose strip: PE andgalvanized iron wire,Ties: Spun-bondpolypropylene	Less than24 hours	Copperphthalocyanine/CAS number:147-14-8).	175x95mm	Tie-on style
DY 97	Outer layer:spunbondpolypropylene,Inner layer: meltblown polypropylene,Nose strip: PE andgalvanized iron wire,Ear loops: Nylon andSpandex	Less than24 hours	Copperphthalocyanine/CAS number:147-14-8).	175x95mm	Ear loop style,the ear loop iswelded on theinner layer.

6. Intended Use / Indications for Use

7. Comparison of Technological Characteristics

The differences between the subject device and predicate devices do not raise new issues of safety or effectiveness.

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Elements ofComparison	Subject Device	Predicate Device	Results
Company	GUANGZHOU MEI YIKANG MEDICALTECHNOLOGY Co., Ltd.	Skypro Medical SuppliesCompany	--
510 (k)	K203646	K152197	--
Trade Name	Disposable Medical Face Mask	Skypro, SP01 Mask	--
ClassificationName	Mask, Surgical	Mask, Surgical	Same
Classification	Class II	Class II	Same
Product Code	FXX	FXX	Same
Intended use	Disposable Medical Face Maskis intended to be worn to protectboth the patient and healthcarepersonnel from transfer ofmicroorganisms, body fluids andparticulate material. This facemask is intended for use ininfection control practices toreduce the potential exposure ofthe wearer to blood and bodyfluids. The mask is a single use,disposable device, providednon-sterile.	The Skypro, SP01 Mask isintended to be worn toprotect both the patient andhealthcare personnel fromtransfer of microorganisms,body fluids, and particulatematerial. These face masksare intended for use ininfection control practices toreduce the potentialexposure of the wearer toblood and body fluids. Themask is a single use,disposable device, providednon-sterile.	Same
Materials
Outer layer	Spunbond Polypropylene	Polypropylene	Same
Middle filter layer	Melt blown Polypropylene	Meltblown	Same
Inner layer	Spunbond Polypropylene	Polypropylene	Same
Nose strip	PE and galvanized iron wire	Metal wires embedded inpolyester or non-woventies	SimilarNote 1
Ear loops for MK-34, DY 95, DY 97	Nylon and Spandex	--	Note 1
Straps for DY 96	Spun-bond polypropylene	--	Note 1
Ear attachment	Eastic earloop (for models MK-34, DY 95, DY 97)	Eastic earloop or Ties	Same
Color	Blue	White	DifferentNote 1
Dimensions	MK-34: 145x95mmDY 95, DY96, DY 97:175x95mm	Gent loop mask size:175x95mmLady loop mask size:145x95mmTie on mask size:175x95mm	Similar
Mask style	Flat pleated	Flat pleated	Same
Design features	3 layers of non---woven fiberwith fiber web in the middle	3 layers of non-woven fiberwith fiber web in the middle	Same
Sterile	Non-SterileSingle use	Non-SterileSingle use	Same
Shelf Life	2 years	Not publicly available	Note 2
Fluid ResistancePerformance	Pass at 120 mm Hg	Pass at 120 mm Hg	Same
ParticulateFiltrationEfficiency	Model MK-34, DY 95 and DY97: 98.9%Model DY 96: 99.3%	99.28%	SimilarNote 3
BacterialFiltrationEfficiency	Model MK-34, DY 95 and DY97: 99.8%Model DY 96: 99.9%	99.66%	SimilarNote 3
DifferentialPressure	Model MK-34, DY 95 and DY97: 4.2 mm H2O/cm²Model DY 96: 4.0mm H2O/cm²	3.72 mm H2O/cm²	SimilarNote 3
Flammability	Class 1	Class 1	Same
Latex	Not made with natural latex	Not made with natural latex	Same
Biocompatibility
Cytotoxicity	Under the conditions of thestudy, Non-cytotoxic	Non-cytotoxic	Same
Irritation	Under the conditions of thestudy, Non-irritating	Non-irritating	Same
Sensitization	Under the conditions of thestudy. Non- sensitization	Non- sensitization	Same

Comparison in Detail(s):

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Note 1:

Although the "Nose strip", "Ear loop", "Straps" and "Color" is a little different from the predicate devices, but it met the ISO 10993 standards and ASTM F2100 level II required. So, the differences between the subject device and the predicate device will not affect the safety and effectiveness.

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Note 2:

Although the "Shelf life" of subject device is different from predicate device, but they all met the ASTM F2100 standard level II required after 81 days accelerated aging under 60°℃, so the difference between subject device and predicate device will not affect the safety and effectiveness.

Note 3: Although the "Particulate Filtration Efficiency ", "Bacterial Filtration Efficiency ", and "Differential Pressure" of subject device is a little different from predicate device, but they all met the ASTM F2100 standard level II required. So, the differences between the subject device and predicate device will not affect the safety and effectiveness.

8. Summary of Non-Clinical Performance Testing

Test item(PerformanceLevel 2 accordingto ASTM F2100)	Test method	Passcriteria	Test results
Bacterial filtrationefficiency	ASTM F2101-14 Standard TestMethod for Evaluating the BacterialFiltration Efficiency (BFE) ofMedical Face Mask Materials,Using a Biological Aerosol ofStaphylococcus aureus accordingto ASTM F2100:2019	≥ 98%	Model MK-34,DY 95 and DY97: 99.8%Model DY96: 99.9%Pass
Differentialpressure (Delta-P)	EN 14683: 2019, Annex C Medicalface masks - Requirements andtest methods according to ASTMF2100:2019	<6.0mmH2O/cm²	Model MK-34,DY 95 and DY97: 4.2 mmH2O/cm²Model DY96: 4.0mmH2O/cm²Pass
Sub-micronparticulate filtrationefficiencyat 0.1 µm ofPolystyrene LatexSpheres	ASTM F2299-03 Standard TestMethod for Determining the InitialEfficiency of Materials Used inMedical Face Masks to Penetrationby Particulates Using LatexSpheres according to ASTMF2100:2019	≥ 98%	Model MK-34,DY 95 and DY97: 98.9%Model DY96: 99.3%Pass

. Performance Testing summary

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penetration bysyntheticblood, minimumpressure in mm Hgfor pass result	Standard Test Method for Resistanceof Medical Face Masks to Penetrationby Synthetic Blood (HorizontalProjection of Fixed Volume at aKnown Velocity) according to ASTMF2100:2019	resistantclaimedat 120mm Hg	Pass at 120mm HgPass
Flame spread	16 CFR Part 1610 Standard for theFlammability of Clothing accordingto ASTM F2100:2019	Class 1	Class 1Pass

● Biocompatibility Testing

According to ISO 10993-1:2009, the nature of body contact for the subject device is Surface Device category, Skin Contact and duration of contact is A-Limited (≤24h). The following tests for the subject device were conducted to demonstrate that the subject device is biocompatible and safe for its intended use:

Test Item	Test Method	Proposed device	Result
Cytotoxicity	ISO 10993-5: 2009 Biologicalevaluation of medical devices-Part 5: Tests for in vitrocytotoxicity	Under the conditions of the study,the subject device extractwas determined to be non-cytotoxic.	PASS
Irritation	ISO 10993-10: 2010 Biologicalevaluation of medical devices-Part 10: Tests for irritation andskin sensitization	Under the conditions of the study,the subject device non-polar andpolar extracts were determinedto be non-irritating.	PASS
Sensitization	ISO 10993-10: 2010 Biologicalevaluation of medical devices-Part 10: Tests for irritation andskin sensitization	Under the conditions of the study,the subject device non-polar andpolar extracts were determinedto be non-sensitizing.	PASS

9. Summary of Clinical Performance Test

No clinical study is included in this submission.

10. Final Conclusion:

The conclusion drawn from the nonclinical test demonstrates that the subject device in 510(K) submission K203646, the Disposable medial face mask is as effective, and performs as well as or better than the legally marketed predicated device cleared under K152197.

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.