The 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. 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 Disposable Medical Face Mask is single use, three-layer, flat-pleated style with ear loops and nose piece. The mask is manufactured with three layers, the inner and outer layers are made of nonwoven fabrics, and the middle layer is made of melt blown fabrics. The ear loops are held in place over the users' mouth and nose by two elastic ear loops welded to the facemask. The elastic ear loops are not made with natural rubber latex. The nose piece in the layers of facemask is to allow the user to fit the facemask around their nose, which is made of galvanized iron wire. The disposable medical face mask will be provided in blue. The masks are sold nonsterile and are intended to be single use, disposable devices.

AI/ML Overview

The provided document describes the acceptance criteria and the study that proves the device (Disposable Medical Face Mask, K202676) meets these criteria. All information is extracted directly from the provided text.

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

Test Methodology	Purpose	Acceptance Criteria	Reported Device Performance
Resistance penetration synthetic blood (Test Method F1862)	To Determine synthetic blood penetration resistance	29 Out of 32 pass at 120 mmHg	Lot 1: 31 out of 32 pass at 120mmHgLot 2: 31 out of 32 pass at 120mmHgLot 3: 32 pass at 120mmHgPass
Particulate Filtration Efficiency (ASTM F2299)	Determine particulate filtration efficiency	≥ 98%	Lot 1: average 99.23%Lot 2: average 99.29%Lot 3: average 99.29%Pass
Bacterial Filtration Efficiency (ASTM F2101)	Determine the bacterial filtration efficiency	≥ 98%	Lot 1: average 99.75%Lot 2: average 99.79%Lot 3: average 99.75%Pass
Differential Pressure (Delta - P) (EN 14683:2019, Annex C)	Determine breathing resistance or differential pressure	< 6.0 mmH₂0/cm²	Lot 1: average 4.07 mm H₂0/cm²Lot 2: average 4.07 mm H₂0/cm²Lot 3: average 4.13 mm H₂0/cm²Pass
Flammability (16 CFR 1610)	Determine flammability	Class 1 (Burn time ≥3.5 s, IBE, or DNI)	Lot 1: Class 1Lot 2: Class 1Lot 3: Class 1Pass
Cytotoxicity (ISO 10993-5)	Determine the effects on cells	The test article should not have potential toxicity to L-929 in the MTT method.	Pass under the conditions of the study, the device is noncytotoxic.
Irritation (ISO 10993-10)	Estimate the potential for contact sensitization	The irritation response category in the rabbit should be negligible.	Pass under the conditions of the study, the device is nonirritating.
Sensitization (ISO 10993- 10)	Estimate the irritation potential of medical device	The test article should not cause delayed dermal contact sensitization in the guinea pig.	Pass under the conditions of the study, the device is nonsensitizing.

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

The sample size is specified for certain tests:

Resistance penetration synthetic blood (ASTM F1862): 32 samples per lot (tested across 3 lots).
For other performance tests (Particulate Filtration Efficiency, Bacterial Filtration Efficiency, Differential Pressure, Flammability), the specific sample size per test is not explicitly stated, but results are provided for 3 lots.
For biocompatibility tests (Cytotoxicity, Irritation, Sensitization), the sample size is not explicitly stated beyond what is implied by the methodology (e.g., L-929 cells, rabbits, guinea pigs).

The data provenance is not explicitly stated in terms of country of origin for the testing, nor whether it was retrospective or prospective. However, the manufacturer is from China (Zhejiang Senhong Medical&Instrument Co., Ltd.) and the submission was made to the US FDA. The studies appear to be laboratory-based non-clinical performance tests.

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

This information is not applicable and not provided. The ground truth for these tests is established by standardized test methodologies and their respective measurement criteria, not by expert consensus or interpretations. For example, for "Resistance penetration synthetic blood," the ground truth is simply whether the specific number of samples passed the physical penetration test at a certain pressure.

4. Adjudication method for the test set

Not applicable. The tests are standardized physical and biological performance assessments, not subjective evaluations 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 disposable medical face mask, not an AI-powered diagnostic or assistive technology. No MRMC study was performed.

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

Not applicable. This is not an algorithm or AI device. The tests are for the physical and biological performance of the mask itself.

7. The type of ground truth used

The ground truth for the device's performance is based on established industry standards and regulatory requirements for medical face masks. This includes:

Physical properties (e.g., filtration efficiency, differential pressure, flammability) measured against quantitative thresholds.
Biocompatibility properties (e.g., cytotoxicity, irritation, sensitization) measured against predefined biological responses.
The "ground truth" is determined by the results of these standardized laboratory tests meeting the pre-defined acceptance criteria.

8. The sample size for the training set

Not applicable. There is no "training set" as this is not an AI/ML device.

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

Not applicable. There is no "training set" for this 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). The logo consists of two parts: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.

November 5, 2021

Zhejiang Senhong Medical&Instrument Co., Ltd. % Boyle Wang Official Correspondent Shanghai Truthful Information Technology Co., Ltd. RM.608, No.738, Shangcheng Rd., Pudong Shanghai, Shanghai 200120 China

Re: K202676

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: September 20, 2021 Received: October 5, 2021

Dear Boyle 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,

For 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) K202676

Device Name Disposable Medical Face Mask

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)

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

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510(k) Summary (K202676)

This summary of 510(k) is being submitted in accordance with requirements of 21 CFR 807.92.

1.0 Submitter's Information

Name: Zhejiang Senhong Medical&Instrument Co., Ltd. Address: Floor 1-2, Building 2, No 889 North Huancheng Rd, Fu'xi Subdistrict, Deqing County, Huzhou, Zhejiang, 313200, China Tel: 86-18006712375 Contact: Eric Jian Date of Preparation: Nov.3,2021

Designated Submission Correspondent

Mr. Boyle Wang Shanghai Truthful Information Technology Co., Ltd. Room 608, No. 738 Shangcheng Rd., Pudong Shanghai, 200120 China Tel: +86-21-50313932 Email: Info@truthful.com.cn

2.0 Device Information

Trade name:	Disposable Medical Face Mask
Common name:	Surgical Face Mask Classification
name:	Surgical Face Mask

3.0 Classification

Production code:	FXX
Regulation number:	21CFR 878.4040
Classification:	Class II
Panel:	Surgical Apparel

4.0 Predicate Device Information

Manufacturer:	WUHAN DYMEX HEALTHCARE CO., LTD.
Device:	SURGICAL FACE MASK
510(k) number:	K182515

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5.0 Device Description

6.0 Indication for Use Statement

Item	Subject DeviceK202676	Predicate DeviceK182515	Remark
Product Name	Disposable Medical FaceMask	Surgical Face Mask	--
Product Code	FXX	FXX	Same
Regulation No.	21 CFR 878.4040	21 CFR 878.4040	Same
Class	II	II	Same
Intended Use&Indications for use	The Disposable Medical FaceMask is intended to be wornto protect both the patientand healthcare personnelfrom transfer ofmicroorganisms, body fluidsand particulate material.These face masks areintended for use in infectioncontrol practices to reducethe potential exposure toblood and body fluids. Thisis a single use, disposabledevice(s), provided non-sterile.	The Surgical FaceMasks are intended to beworn to protect both thepatient and healthcarepersonnel from transferof microorganisms, bodyfluids and particulatematerial. These facemasks are intended foruse in infection controlpractices to reduce thepotential exposure toblood and body fluids.This is a single use,disposable device(s),provided non-sterile.	Same

Table 1 General Comparison

7.0 Technological Characteristics Comparison to the Predicate Device

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Design features
Mask Styles	Ear Loops, 3 layers	Ear Loops, 3 layers	Same
	Flat pleated	Flat pleated	Same
Material	Outer facing layer	Nonwoven fabrics	Spun-bond polypropylene	Same
	Middle layer	Melt blown fabrics	Melt blown polypropylene filter	Same
	Inner Facing layer	Nonwoven fabrics	Spun-bond polypropylene	Same
	Nose piece	Galvanized iron wire	Malleable polyethylene wire	Different*
	Ear loops	not made with natural rubber latex	not made with natural rubber latex	Same
	Color	Blue	Blue	Same
	Dimension (Length)	17.5 cm +/- 1cm	17.5 cm +/- 1cm	Same
	Dimension (Width)	9.5 cm +/- 1cm	9.5 cm +/- 1cm	Same
	OTC use	Yes	Yes	Same
	Sterility	Non-Sterile	Non-Sterile	Same
	Single Use	Yes	Yes	Same
	Sterile	No	No	Same
	ASTM F2100 Level	Level 2	Level 2	Same

*The difference in the materials does not raise additional questions for safety and effectiveness. Performance testing including biocompatibility evaluation has been performed on the final finished device which includes all construction materials.

8.0 Non-Clinical Test Conclusion

The proposed device was tested and conformed to the following standards and the requirements stated in the Guidance for Industry and FDA Staff: Surgical Masks -Premarket Notification [510(k)] Submission issued on March 5, 2004.

Table 2 - Performance Testing

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TestMethodology	Purpose	AcceptanceCriteria	Result
Resistancepenetrationsynthetic blood	to Determine syntheticbyblood penetrationresistance as specifiedin TestMethod F1862	29 Out of 32 passat 120 mmHg	Lot 1:31 out of 32 pass at120mmHgLot 2:31 out of 32 pass at120mmHgLot 3:32 pass at 120mmHgPass
ParticulateFiltrationEfficiencyASTM F2299	Determine particulatefiltration efficiency asdirected in Test MethodF2299.	≥ 98%	Lot 1: average 99.23%Lot 2: average 99.29%Lot 3: average 99.29%Pass
BacterialFiltrationEfficiencyASTM F2101	Determine the bacterialfiltration efficiency asdirected in Test MethodASTM F2101.	≥ 98%	Lot 1: average 99.75%Lot 2: average 99.79%Lot 3: average 99.75%Pass
DifferentialPressure(Delta - P)	Determinebreathingresistance or differentialpressure as directed inEN 14683:2019, AnnexC.	< 6.0mmH₂0/cm²	Lot 1:average 4.07 mm H₂0/cm²Lot 2:average 4.07 mm H₂0/cm²Lot 3:average 4.13 mm H₂0/cm²Pass
Flammability16 CFR 1610	Determine flammabilityas specified in 16 CFRPart 1610	Class 1(Burn time≥3.5 s, IBE, orDNI)	Lot 1: Class 1Lot 2: Class 1Lot 3: Class 1Pass

Table 3 - Biocompatibility Testing

Test Methodology	Purpose	Acceptance Criteria	Result
Cytotoxicity	Determine the effectson cells following ISO10993-5	The test article should nothave potential toxicity toL-929 in the MTTmethod.	Pass under the conditionsof the study, the device isnoncytotoxic.
Irritation	Estimate the potentialfor contactsensitization followingISO 10993-10	The irritation responsecategory in the rabbitshould be negligible.	Pass under the conditionsof the study, the device isnonirritating.
Sensitization	Estimate the irritationpotential of medicaldevice following ISO10993- 10	The test article should notcause delayed dermalcontact sensitization in theguinea pig.	Pass under the conditionsof the study, the device isnonsensitizing.

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9.0 Clinical Test Conclusion

No clinical study is included in this submission.

10.0 Conclusion

The conclusion drawn from the non-clinical tests demonstrates that the subject device is as safe, as effective, and performs as well as or better than the legally marketed predicate device in K182515.

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.